Enhancing functional level and quality of life of community-dwelling older people with walking difficulties through intermittent pneumatic compression intervention. A randomized controlled trial

General Information
WDRPA Clinical Trial Registration No: WDRPACTR 2019/001
Recruitment Status: Completed
Date of first posted: 23 Augut 2019
Date of last updated: 15 October 2019
Contacts : Dr. W.M. Sujeewa Weerasinghe , Tel :0094714839710, weerasinghe.sujeewa@gmail.com, Physiolife Care, Ruwanwella, Sri Lanka.
Locations: MOH areas of Ruwanwella,Yatiyanthota and Bulathkohupitiya of Kegalle, Sri Lanka
Sponsor: MAS Holdings
Collaborator: N/A
Information provided by (Responsible Party): Dr. W.M. Sujeewa Weerasinghe

Study Description
Brief Summary:

Background: Walking difficulty is a common problem in older adults and may greatly affect the quality of life (QOL) and restrict the personal independence and participation. Objectives: To determine the effect of intermittent pneumatic compression (IPC) on the pain, walking capacity, functional mobility, ankle range of motion (AROM) and QOL of community dwelling older people with walking difficulties. Design: This study will be a randomized controlled trial. Method: Seventy eligible participants with self-reported lower limb pain and walking difficulty will be randomized either to intermittent pneumatic compression intervention group (IPCIG) or static compression control group (SCCG). The IPCIG and SCCG  will receive IPC and static compression (SC) respectively, for 7 days per week for 4 weeks twice a day. Outcome measures of pain in lower legs, AROM, walking capacity, functional mobility will be assessed at baseline, 1st, 2nd, 3rd and 4th weeks after randomization. QOL will be assed at baseline and immediate post intervention. Conclusion: The IPC may be effective in reducing lower leg pain and increasing the ankle range of motion and improving the walking capacity, functional mobility level and QOL of community dwelling older people with walking disabilities. Impact: Walking disability in old age is a common condition referred for physiotherapy. IPC if found effective can be used as a physiotherapeutic modality in treatment of this patient group.
Detailed Description:

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. Therefore, the objectives of this study are: 1. To determine the effect of 4 week IPC to lower legs on lower limb pain   in community dwelling elderly people with walking difficulties. 2. To determine the effect of 4 week IPC to lower legs on walking capacity in community dwelling elderly people with walking difficulties. 3. To determine the effect of 4 week IPC to lower legs on functional mobility in community dwelling elderly people walking difficulties. 4. To determine the effect of 4week IPC to lower legs on quality of life in community dwelling elderly people with walking difficulties. 5. 4.To determine the effect of 4week IPC to lower legs on ankle range of motion in community dwelling elderly people with walking difficulties.
Condition or disease : Walking difficulty
Intervention/treatment : Intermittent Pneumatic Compression
Phase : N/A

Study Design
Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Single-blinded design.
Primary Purpose: Treatment
Official Title: Enhancing functional level and quality of life of community-dwelling older people with walking difficulties through intermittent pneumatic compression intervention. A randomized controlled trial
Study Start Date: 25 August 2019
Primary Completion Date: 25 September 2019
Study completion Date: 30 September 2019

Arms and Interventions
Control Intervention:
 Control intervention is the application of static compression to both lower legs for 15 minutes daily for 12 weeks with the conventional compression garment. The intervention should be performed in seated position. 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.

Experimental Intervention:

Participants of the IPCIG will be received instructions and training by a physiotherapist on application of IPC to both lower legs for 15 minutes per session, twice a day, 7 days per week for 4 weeks with the Spryng™ Calf Wrap, Model No: SPRCW1, an IPC device. Low compression Intensity of 30mmHg – 50mmHg and graduated compression (wavetec™) pattern will be used for the IPC which will be used in seated position.  In the wavetec™ compression profile, the lower calf is compressed initially to a peak pressure value before the lower calf reaches its peak value, the mid-calf region is compressed to its peak pressure, which is lower than the lower calf pressure. Similarly, the top calf begins to be compressed before the mid-calf reaches its peak value. Each participant of the intervention group will be trained about the application of the IPC device 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.

Outcome Measures
Primary Outcome Measures:
1.  Quality of Life ( SF 36)
Secondary Outcome Measures:
1. Pain in the lower leg  (NPRS)
2. Walking capacity  (6MWT)
3. Functional Mobility (TUG test)
4. Ankle range of motion

Eligibility Criteria
Information from the WDRPACTR
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Be aware about the risks and potential benefits of clinical studies and talk to your health care provider before participating. Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
Inclusion Criteria:
Inclusion criteria include 1.self-reported lower limb pain and walking difficulty, 2. Currently seeking care for pain and walking difficulty, 3.Age above 60 years and 4. Ability to understand the instructions.
Exclusion Criteria:
Exclusion criteria are presence of, 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, 6.Wounds, lesions, or tumors at or near the site of application where increased venous and lymphatic return is undesirable, 7.Bone fractures or dislocations at or near the site of application, 8.Pregnant and postnatal women, 9.People using implantable equipment like cardiac pacemakers, 10.People with skeleton injuries and diseases, 11. Cancer, 12.High blood pressure or abnormal blood pressure, 13. Severe atherosclerosis or other ischemic vascular diseases, 14. Severe congestive cardiac failure, 15. Existing pulmonary embolism 16.Extreme deformity of the limbs limited to, gangrene, untreated or infected wounds, recent skin graft, and dermatitis 17.Known presence of malignancy in the legs 18.Limb infections, including cellulitis, that have not received antibiotic coverage, 19.Presence of Lymphangiosarcoma.

Contacts and Locations
Information from the WDRPACTR
To learn more details about this study you or your Doctor or Health care provider may contact the study research staff by using the contact information provided by the principal investigator. Refer the registration number WDRPACTR 2019/001.
Locations: MOH areas of Ruwanwella,Yatiyanthota and Bulathkohupitiya of Kegalle, Sri Lanka
Sponsor: MAS Holdings
Collaborator: N/A
Principal Investigator:  Dr. W.M. Sujeewa Weerasinghe , Tel :0094714839710, weerasinghe.sujeewa@gmail.com, Physiolife Care, Ruwanwella, Sri Lanka.
Locations: MOH areas of Ruwanwella,Yatiyanthota and Bulathkohupitiya of Kegalle, Sri Lanka
Keywords provided:
Walking difficulty, pain, pneumatic compression, elderly