Enhancing Functional Level and Quality of Life of Community Dwelling Older People with Walking Disabilities through “Dynamic Compression Garment” Training Intervention A single-blinded randomized controlled trial W.M.S.Weerasinghe1,T.M.U.S.Thunpaththu2,W.M.S.A.Weerasinghe3,W.M.S.T.Weerasinghe4,P.W.G.S.Walpola5,D.M.T.P.Dissanayake6, D.A.R.K.Dasanayaka7 Physio life care, Sri Lanka National Hospital of Sri Lanka Ministry of child development and women affairs, Sri Lanka University of Peradeniya, Sri Lanka

Study Proposal

 

Enhancing Functional Level and Quality of Life of Community Dwelling Older People with Walking Disabilities through “Dynamic Compression Garment” TrainingIntervention

 A single-blinded randomized controlled trial

W.M.S.Weerasinghe1,T.M.U.S.Thunpaththu2,W.M.S.A.Weerasinghe3,W.M.S.T.Weerasinghe4,P.W.G.S.Walpola5,D.M.T.P.Dissanayake6, D.A.R.K.Dasanayaka7

Physio life care, Sri Lanka

National Hospital of Sri Lanka

Ministry of child development and women affairs, Sri Lanka

University of Peradeniya, Sri Lanka

 

 

 

 

 

 

 

 

  1. 1.        

Title:

Enhancing functional level and Quality of life of community-dwelling older people with walking difficulties through “dynamic compression garment” training intervention.

  1. 2.        

Objective

To determine the effects of 4 week dynamic compression to lower legs with “dynamic  compression garment” training intervention in community dwelling elderly people with walking difficulties in Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya.

  1. 3.        

Study design

A single-blinded randomized controlled trial.

  1. 4.        

Study setting

Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya.

  1. 5.        

Study population

Individuals aged 60 years or more and who have self-reported lower leg pain and walking difficulties

  1. 6.        

Definition of intervention/main exposure variable

Dynamic compression will be applied for 15 minutes daily to the lower leg (bilateral) by using a “dynamic compression garment”. Recommendations for home program will be provided.

 

  1. 7.        

Definition of primary outcome

Quality of Life ( SF 36)

  1. 8.        

Sample size

34 older adults over 60 years of age

  1. 9.        

Data collection method

 

Using SF 36 questionnaire

 

  1. 10.    

Proposed data analysis

Descriptive analysis of data will be conducted to find out the distribution of data of treatment group and control group at the baseline and weekly until four weeks, and result will be shown in graphs and tables. The four dependent variables; pain in the lower legs, walking capacity, , Functional mobility and quality of life will be compared within the group using one way repeated measure ANOVA and between the groups using two way repeated measure ANOVA. Independent two sample test will be conducted to compare male and female outcomes at the end of the study. Risk difference, number needed to treat and relative risk will be calculated end of the trail for all the variables to find the effectiveness of the application of the garment and more than 80% improvement consider as the cutout mark.

  1. 11.    

Main ethical issues

 

The dynamic compression training has not been tested in elderly patients.

 

 

 

 

1. Title

Enhancing functional level and Quality of life of community-dwelling older people with walking difficulties through “dynamic compression garment” training intervention. A single-blinded randomized controlled trial.

2. Introduction and Background

Walking is a common activity of daily living and at the same times a very complex task. It involves all levels of the nervous system and many parts of the musculoskeletal system as well as the cardiorespiratory system. (1) Walking difficulty is a common problem in older adults. (2-6)

The walking disability develops gradually, and many older adults are referred (or self-refer) to a geriatric specialist because of the mobility problem.(1) The prevalence of gait and balance disorders markedly increases with age, from around 10% between the ages of 60 and 69 years to more than 60% in those over 80 years.(7) Gait impairments and walking difficulties may greatly affect the quality of life of the elders (7) and restrict the personal independence of those affected. (2-6)

Interventions to improve walking have historically been multifactorial. Commonly used exercise interventions in elderly subjects are muscle strengthening, power and resistance training as well as coordination training.(8) However these multifactorial impairment-based programs have resulted in only modest improvements in walking (eg an approximate 5% increase in gait speed, with a range of 0-16%). (9-20) Therefore there is a need to identify interventions that may be useful in improving walking capacity and hence functional level and quality of life and can be applied simply to the elderly population.

On the other hand, the application of the static compression on lower leg has been investigated for various conditions. Traditional lower limb compression garments are increasingly popular among athletes who wish to improve performance and to reduce exercise-induced discomfort and injury risk (21) Furthermore, compression stockings have wide, evidence-based application for treating clinical pathologies such as deep vein thrombosis and chronic venous insufficiency (22,23) The impact of compression therapy during exercise or during recovery and its clinical outcome regarding delayed onset muscle soreness has also been investigated (21,24-26)

However there is a scarcity of studies to investigate the effect of application of dynamic compression to the lower leg. Furthermore the effect of dynamic lower leg muscle compression on walking in any cohort has not been investigated. Therefore an intervention such as dynamic lower leg muscle compression, which may optimizes walking capacity, functional mobility and quality of life would be a logical intervention for older persons with walking difficulties.

3. Purpose of Study/ Objectives

The purpose of this study is to investigate the effect of application of dynamic compression garment on the walking capacity, functional mobility level and quality of life of community dwelling older people with walking disabilities.

3.1 General Objective:

To determine the effects of 4 week dynamic compression to lower legs with “dynamic  compression garment” training intervention in community dwelling elderly people with walking difficulties in Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya.

3.2 Specific objectives:

1. To determine the effect of 4 week dynamic compression to lower legs with “dynamic compression garment” on lower limb pain and ROM of B/L Ankle joints    in community dwelling elderly people with walking difficulties.

2. To determine the effect of 4 week dynamic compression to lower legs with “dynamic compression garment” on walking capacity  in community dwelling elderly people with walking difficulties.

3. To determine the effect of 4 week dynamic compression to lower legs with “dynamic compression garment” on functional mobility in community dwelling elderly people walking difficulties.

4. To determine the effect of 4 week dynamic compression to lower legs with “dynamic compression garment” on quality of life in community dwelling elderly people with walking difficulties.

5. To evaluate the relationship between ROM of B/L Ankle joints,   walking capacity and functional mobility /quality of life in community dwelling elderly people with walking difficulties

4. Theoretical Frame work & Review of Literature / Rationale

One of the reason for difficult in walking in many older adults is swollen legs and ankles which may causes pain in the legs and stiffness in ankle joints. Legs, ankles, and feet swell when excess fluid is pulled down by gravity. This would be aggravated when the calf muscle pump is not occurring properly specially in inactive elders. Lack of exercise or sitting or standing still for too long is a common cause for this problem. The difficulty in walking will make the elders more inactivity and the inactivity and walking difficulty occurs in a vicious cycle. This problem can be solved if fluids can be pumped up from the feet and ankle. The dynamic compression application Dynamic compression garment will made this upward pump and therefore reduces the swelling and therefore the pain occurred due to swelling in lower legs. This leads to improve the walking capacity and will break the vicious cycle of inactivity and swelling.

It has been suggested that the benefits of massage may help to enhance dynamic balance (27) Balance may be maintained by using an ankle strategy, hip strategy, or both strategies at the same time. In particular, the ankle strategy functions in the early stages of balancing to facilitate control over external sway (28, 29). The soleus muscle, which provides stability to the ankle joint and acts in push off at the end of the stance phase during walking. The gastrocnemius muscle maintains the weight center of the basal area through continuous muscle contraction during walking and generates sufficient muscle strength to maintain stability during exercise of the lower limbs (30, 31). It has been shown that calf massage is effective in improving the balance ability of the ankle joint. Massage applied to the calf is a useful method to improve the balance of elderly people who have diminished balancing abilities due to problems with their plantar-flexion torque. (32)

The Dynamic compression garment intervention provides a massage effect to the calf muscles (soleus and gastrocnemius muscles). Therefore the application of Dynamic compression garment may improve the balance of the elders.

Another deficits characteristic of age-related walking problems which contributes to inefficient gait is decreased ankle plantar flexion and power at push off (33-37) .Studies have shown that the massage of the calf muscle has improve the ankle joint flexibility.(32) Therefore application of the Dynamic compression garment intervention may also improve the flexibility of the ankle joint and hence increase the walking capacity and balance.

Enhancing aerobic capacity may provide the energy needed to sustain the muscle activity the older adult uses for walking and reduce restriction of walking activity in prolonged walking conditions. (38,39) . Aerobic conditioning exercise enhances the delivery and extraction of oxygen to the muscles, necessary to sustain the repeated pattern of muscle activation in walking. The Dynamic compression garment application will improve the circulation to the muscles in the lower leg and foot and therefore may improve the walking activity in older adults.

Therefore application of dynamic lower leg muscle compression with Dynamic compression garment which may optimizes walking capacity and functional mobility. The improvements in walking capacity and functional mobility will be supportive for the better performance of activities of daily living and independent life and therefore the quality of life of community dwelling older persons with walking difficulties.

 

5. Questions and/or Hypotheses

1. Does application of 4 week dynamic compression to lower legs with “Dynamic compression garment” reduce the lower limb pain   in community dwelling elderly people with walking difficulties?

2. Does application of 4 week dynamic compression to lower legs with Dynamic “compression garment” improve the walking capacity in community dwelling elderly people with walking difficulties?

3. Does application of 4 week dynamic compression to lower legs with Dynamic compression garment” improve the functional mobility in community dwelling elderly people walking difficulties?

4. Does application of 4 week dynamic compression to lower legs with Dynamic compression garment” improve the quality of life in community dwelling elderly people with walking difficulties?

6. Methodology (design, methods, procedures)

6.1. Study type/design

This study is designed as a single blind randomized control trial.

6.2. Study Setting

Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya of the Kegalle district are selected as the study area for this study.

6.3. Study period

This study will be conducted from 15th of August 2019 to 16th September 2019

6.4. Study population

Individuals aged 60 years or more and who have self-reported lower leg pain and walking difficulties in the Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya of the Kegalle district will be recruited for this study.

6. 4. 1 Inclusion criteria:

Participants fulfilling all of the following inclusion criteria are eligible for the study:

  1. Self-reported musculoskeletal lower limb pain and walking difficulty
  2. Currently seeking care for walking difficulty.
  3. Age above 60 years.
  4. Ability to understand the instructions.

6.4.2 Exclusion criteria:

The presence of any one of the following exclusion criteria will lead to exclusion of the participant

  1. Acute pulmonary edema
  2. Acute thrombophlebitis
  3. Acute congestive cardiac failure
  4. Acute infections
  5. Deep vein thrombosis (DVT)
  6. Episodes of pulmonary embolism
  7. Wounds, lesions, or tumors at or near the site of application where increased venous and lymphatic return is undesirable
  8. Bone fractures or dislocations at or near the site of application
  9. Pregnant and postnatal women
  10. People using implantable equipment like cardiac pacemakers.
  11. People with skeleton injuries and diseases
  12. Cancer
  13. High blood pressure or abnormal blood pressure
  14. Severe atherosclerosis or other ischemic vascular diseases
  15. Severe congestive cardiac failure
  16. Existing pulmonary embolism
  17. Extreme deformity of the limbs limited to, gangrene, untreated or infected wounds, recent skin graft, and dermatitis
  18. Known presence of malignancy in the legs
  19. Limb infections, including cellulitis, that have not received antibiotic coverage
  20. Presence of Lymphangiosarcoma

6.5. Calculation of sample size

Thirty fore (34) community dwelling individuals aged 60 years or more, who have walking difficulties and pain in lower leg in the Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya of the Kegalle district, will be recruited for this study.

6.6. Sampling technique, Recruitment and Randomization

It is expected to receive the information of potential participants through self-presentation, public health midwives of Medical Officer of Health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya. And ‘Grama Niladhari’ officers and social service officers of theof Ruwanwella, Yatiyanthota and Bulathkoupitiya divisional secretariats according to the four recruitment strategies mentioned under the sampling technique. Participants will be included according to the inclusion and exclusion criteria and will be registered to the study with obtaining their informed consent. Consecutive sampling method will be used to recruit participants for the study. A recruitment notice will be used to inform the study to potential participants. (Appendix) Sinhala and Tamil versions of the recruitment notice are available to use as appropriate for the language of participants. (Appendix)

Four recruitment strategies will be used to optimize the participation. The first strategy involves disseminating recruitment notices and obtaining the information of potential participants through public health midwives. The second strategy involves disseminating recruitment notices and obtaining the information of potential participants through ‘Grama Niladhari’ officers. The third strategy involves disseminating recruitment notices and obtaining the information of potential participants through social service officers of the divisional secretariat. The fourth strategy involves displaying recruitment notices in public places.

Participants who are selected for the study will be randomly assigned, to intervention group (IG) to undergo application of Dynamic compression garment intervention and usual to control group (CG) to undergo application of static compression by conventional compression garments. A computer generated randomization table will be used, and individual allocations will be placed in sealed envelopes. Randomization will be done by an independent investigator who will not participate in outcome measures and data collection (II 01).

6.7 Outcome Measures

6.7.1 Primary outcome

The primary outcome measure is the quality of life and will be assessed by using SF36 questionnaire.

6.7.2 Secondary outcomes

Secondary outcome measures are the reduction of the pain in lower legs, ROM of B/L Ankle joints, walking capacity and functional mobility. These will be assessed with numerical pain rating scale, Goniometer, six minute walk test and the timed up and go test respectively.

6.7.3 Compliance data

Attendance at training sessions will be recorded for all participants. All participants will be asked to complete a tick-box diary to record compliance with their home exercise programme. The participants’ satisfaction and motivation will be measured by using 10-point scale.

 

6.8. Study instruments

Socio-demographic data will be collected by using an interviewer administered questionnaire. Following instruments will be used to collect the data on outcome measures.(Appendix)

Numerical Pain Rating Scale (NPRS) for pain (Appendix)

Six minute walk Test (6MWT) (Appendix)

Timed Up and Go test (TUG) (Appendix)

SF 36 questionnaire (Appendix)

Goniometer will be used to measure ROM of B/L Ankle joints (Appendix)

10 point scales will be used to measure the participants’ satisfaction and motivation to the interventions. (Appendix)

Any adverse event, unexpected occurrences and identified potential risks during the intervention will be recorded in order to assess the safety of application of dynamic compression to lower legs with Dynamic compression garment.

6.9 The interventions

The intervention group will receive the dynamic compression intervention with the Spryng®Med. Spryng®Med is a compression garment which can be used to provide a dynamic compression to the lower leg.  The control group will receive the static compression intervention with the conventional compression garments.

6.9.1 Experimental Intervention

Experimental intervention is the application of dynamic compression to both lower legs for 15 minutes daily for 4 weeks with the SPRYNG™ MED. Low compression Intensity of 20mmHg – 40mmHg and graduated compression patterns will be used for the intervention. The intervention should be performed in seated position. (Picture 1)  Each participant of the intervention group will be trained about the application of the dynamic compression with SPRYNG™ MED at baseline of the study. The applications will be supervised at the second, fourth and eighth day of the commencement of the intervention and further training on home application (by self or family member) will be provided if necessary.

6.9.2 Control Intervention

Control intervention is the application of static compression to both lower legs for 15 minutes daily for 4 weeks with the conventional compression garment. The intervention should be performed in seated position. (Picture 2) Each participant of the control group will be trained about the application of the static compression with conventional compression garment at baseline of the study. The applications will be supervised at the second, fourth and eighth day of the commencement of the intervention and further training on home application (by self or family member) will be provided if necessary.

All interventions and trainings will be delivered by experienced physiotherapists in managing elderly people and trained in the standard protocols on provision of the dynamic compression intervention to the lower legs by using Spryng®Med and static compression to the lower legs by using conventional compression garments.

 

 

 

 

 

Picture 1

Picture 2

 

6. 10. Plans for data collection including training of data collectors

Demographic data will be collected by the independent investigator at the base line of the study. Data on outcome measures will be collected by another independent investigator who is blinded for the group allocation and having a knowledge about examination of the participants for those outcome measures. Participants will be assessed on each outcome at baseline, at 1, 2, 3, and 4 weeks after the commencement of the intervention.

Training on data collection will be provided for all data collectors prior to the commencement of the study.

6.11. Data Analysis

Descriptive analysis of data will be conducted to find out the distribution of data of treatment group and control group at the baseline and weekly until four months, and result will be shown in graphs and tables. The four dependent variables; pain in the lower legs, walking capacity, , Functional mobility and quality of life will be compared within the group using one way repeated measure ANOVA and between the groups using two way repeated measure ANOVA. Independent two sample test will be conducted to compare male and female outcomes at the end of the study. Risk difference, number needed to treat and relative risk will be calculated end of the trail for all the variables to find the effectiveness of the application of the garment and more than 80% improvement consider as the cutout mark.

 6.12. Administrative requirements

Prior approval will be obtained from the medical officer of health (MOH) areas of Ruwanwella, Yatiyanthota and Bulathkoupitiya to obtain the support of the public health midwives to disseminate the notice of recruitment and get the information about potential participants. Prior approval will be obtained from divisional secretaries of Ruwanwella, Yatiyanthota and Bulathkoupitiya divisional secretariat to obtain the support of Grama Niladhari officers and social service officers to disseminate the notice of recruitment and get the information about potential participants. Approval will be obtained from the heads or persons in charge of the relevant public places prior to the displaying the recruitment notices.

6.13. Ethical issues and clearance

Ethical clearance for this study will be obtained from the ethics review committee of the Chartered society of Physiotherapy Sri Lanka. Informed consent will be obtained from all the participants of the study. An information sheet and a consent form will be used for this purpose. (Appendix) Sinhala and Tamil versions of the information sheet and consent form are available to use as appropriate for the language of participants. (Appendix)

The participants will be informed of the study before it begins; anonymity will be guaranteed. The nature, conduct, and potential risks and benefits of the study will be fully explained to the participants. The participants will be made aware that their participation is entirely voluntary and that refusing to take part will not have a negative impact on the usual care provided by the service.

6.14 Withdrawal criteria / safety considerations

Patients will be provided with adequate amount of time to consider their participation in the trial and will be given an opportunity to ask questions. If the patient decides to participate in the study, they will be asked to provide written consent, which will then be countersigned by the investigator. All participants are free to withdraw from the study at any time, without any prejudice to future medical treatment. Intervention will be carried out under supervision of the physiotherapists and patients will be assessed before, during and after the intervention for any adverse events. They will be given assurances throughout the study that their data will be kept confidential. The research personnel involved will work closely with the participants to monitor the occurrence of any untoward effects on the participants. Standard guidelines for the management of will be used. The involvements of the research team and the aforementioned monitoring and safety procedures have been specifically designed to minimize any potential risks to the physical health of the participants. A qualified medical officer will examine all the participants before and after the study intervention.

7. Significance of the Study

The older population of the world is increasing rapidly. By 2050, the world’s population aged 60 years and older is expected to total 2 billion, up from 900 million in 2015. The aging may be a reason a person to become to the state of “care dependence”, which arises when functional ability has fallen to a point where an individual is no longer able to undertake the basic tasks that are necessary for daily life without the assistance of others. (40) Among other reasons, one of the major reasons to become dependent in elderly is difficulties of walking. In the context of development and economy, old-age dependence is generally portrayed as a negative state resulting in the transfer of benefits from younger, presumably more productive generations to older ones. This worldwide problem can be answered if the state of dependency among elders can be reduced, by preventing the walking difficulties and improving walking ability, improving the functional level and quality of life.

Engaging in physical activity across the life course has many benefits, including increasing longevity. For example, a recent pooled analysis of large longitudinal studies found that people who engaged in 150 minutes per week of physical activity at moderate intensity had a 31% reduction in mortality compared with those who were less active. The benefit was greatest in those older than 60 years(41). Physical activity has multiple other benefits in older age. These include improving physical and mental capacities (for example, by maintaining muscle strength and cognitive function, reducing anxiety and depression, and improving self-esteem); preventing disease and reducing risk (for example, of coronary heart disease, diabetes and stroke); and improving social outcomes (for example, by increasing community involvement, and maintaining social networks and intergenerational links). These benefits can be substantial. For example, both cross-sectional and longitudinal studies have suggested there is a 50% reduction in the relative risk of developing functional limitations among those reporting regular and at least moderate-intensity physical activity (42, 43). Physical activity also appears to preserve, and may even improve, cognitive function in people without dementia (42, 44), reducing cognitive decline by around one third (45).

In addition, physical activity protects against some of the most important health conditions in older age. Physical inactivity may account for up to 20% of the population-attributable risk of dementia, and it has been estimated that 10 million new cases globally might be avoided each year if older adults met recommendations for physical activity (46). Similarly, stroke causes some of the greatest burden of disease in older age, and moderate physical activity may reduce the risk by 11–15%, and vigorous physical activity has even greater benefits, reducing the risk by 19–22% (47). Walking is the mostly used aerobic physical activity and main mode of aerobic exercise among older adults. Therefore improving the walking ability of elders would be an important intervention to achieve most of the above mentioned health and social benefits.

The outcome of this study would be useful to determine the effect of “Dynamic compression garment” training intervention on enhancing walking ability, functional level and quality of life of community dwelling older people with walking disabilities and hence provide a considerable answer for the significant problem of rapid aging of the populations in the world. Results of this study will be presented at scientific meetings and published in peer-reviewed journals.  Also the results will be disseminating through the media for the betterment of the society.

8. Time Schedule

Specify Activity

July 2019

Aug 2019

Sep 2019

Oct 2019

Nov 2019

Literature Survey

 

 

 

 

 

Proposal Writing

 

 

 

 

 

Ethical Clearance

 

 

 

 

 

Planning Data Collection

 

 

 

 

 

Data Collection

 

 

 

 

 

Data Entry

 

 

 

 

 

Data Analyses

 

 

 

 

 

Report Writing

 

 

 

 

 

 

7. Budget

Appendix

 

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