Chronic Kidney Disease stage4, Chronic Kidney Disease Stage V, Physical Activity
Conditions
Keywords
implementation
Brief summary
The investigators plan to integrate and tailor the existing Exercise is Medicine framework, an evidence-based multi-level intervention program developed by the American Society of Sports Medicine, for the care of patients with advanced chronic kidney disease. In this pilot randomized control trial, investigators will compare the effects and feasibility of two intervention arms designed to start and maintain physical activity in this high-risk population (Group 1: physical activity assessment, brief counseling session + physical activity wearable versus Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program).
Detailed description
Persons on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Physical inactivity in turn increases the risk for functional decline and mortality in this vulnerable population. The investigators propose a pragmatic clinical trial for an exercise intervention among persons transitioning to dialysis. The investigators will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. The investigators will randomize 98 persons from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8 week follow up). The investigators will assess efficacy by comparing between group differences in minutes/week of (measured) moderate intensity physical activity. To evaluate implementation, investigators will use questionnaires and exit interviews for assessing barriers to referral, participation and retention along the path of the intervention; investigators will use cost-utility analyses to assess scalability. Further the investigators will have a plan for dissemination of the intervention by partnering with insurance providers and both for-profit and non-profit dialysis organizations. The overall goal is to inform the development of a practical, cost-conscious intervention that addresses barriers to physical activity commonly faced by persons on dialysis, and can be delivered as a package to interested practices.
Interventions
BEHAVIORALEIM Fitness Practitioners
Exercise is Medicine Practitioners will facilitate peer groups that attend twice-weekly exercise classes for 8 weeks, with clinical monitoring and advise regarding increasing physical activity.
BEHAVIORALCounseling and wearable device
Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.
Sponsors
Emory University
Santa Clara Valley Medical Center
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \- eGFR \< 30 ml/min/1.73m2 * Age ≥30 and ≤80 years * Noncompliance with physical activity guidelines * Not in precontemplation stage * Non-wheelchair bound * Able to provide informed consent in English or Spanish * Anticipated to be living in the area over the next 36 weeks
Exclusion criteria
* \- Inability to provide consent in English * Diagnosed mental health disorder * Alcohol or drug abuse * No fixed address or contact details * Unstable angina or unstable arrhythmias * Lack of access to internet * Any concern not otherwise stated by patient's nephrologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in minutes of physical activity per week as measured by wearable device | measured at baseline, 8 weeks and 16 weeks post start of intervention. | The Garmin wearable device will be used to track physical activity minutes during the week, with differences in total minutes per week in baseline versus 8 weeks (and 16 weeks) post intervention compared between exercise classes versus counseling alone groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test (6MWT) | measured at baseline, 8 weeks and 16 weeks post start of intervention. | 6 minute walk test will be administered by research personnel in 100 feet walkway, with differences in distance walked between baseline and 8 weeks (and 16 weeks), compared between group exercise and counseling alone groups |
| Handgrip | measured at baseline, 8 weeks and 16 weeks post start of intervention. | Dynamometers will be used to measure handgrip strength, with differences in distance walked between baseline and 8 weeks (and 16 weeks), compared between group exercise and counseling alone groups |
| Health-related Quality of life using Medical Outcomes Short form 12 | measured at baseline, 8 weeks and 16 weeks post start of intervention. | Questionnaire based Sf12 will be used to measure health related quality of life, with differences in distance walked between baseline and 8 weeks (and 16 weeks), compared between group exercise and counseling alone groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | measured at baseline, 8 weeks and 16 weeks post start of intervention. | — |
| Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20) | measured at baseline, 8 weeks and 16 weeks post start of intervention. | Questionnaire based CESD-2 scale will be used to measure depression |
| Physical activity self-efficacy questionnaire | measured at baseline, 8 weeks and 16 weeks post start of intervention. | — |
Countries
United States
Outcome results
None listed