Clinical trial NCT03311763: Exercise is Medicine for Patients With CKD
Official title: A Multi-center Exercise Intervention for Persons Transitioning to Dialysis Using the "Exercise is Medicine" Framework
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease stage4
Chronic Kidney Disease Stage V
Physical Activity
Keywords: implementation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Emory University
name: Santa Clara Valley Medical Center
First posted: 2017-10-17
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in minutes of physical activity per week as measured by wearable device
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
Secondary outcomes:
measure: Six minute walk test (6MWT)
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
measure: Handgrip
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
measure: Health-related Quality of life using Medical Outcomes Short form 12
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
Other outcomes:
measure: Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20)
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
measure: Physical activity self-efficacy questionnaire
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
measure: Waist circumference
timeFrame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Nephrology
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
citation: Anand S, Ziolkowski SL, Bootwala A, Li J, Pham N, Cobb J, Lobelo F. Group-Based Exercise in CKD Stage 3b to 4: A Randomized Clinical Trial. Kidney Med. 2021 Jul 8;3(6):951-961.e1. doi: 10.1016/j.xkme.2021.04.022. eCollection 2021 Nov-Dec.
citation: Jagannathan R, Ziolkowski SL, Weber MB, Cobb J, Pham N, Long J, Anand S, Lobelo F. Physical activity promotion for patients transitioning to dialysis using the "Exercise is Medicine" framework: a multi-center randomized pragmatic trial (EIM-CKD trial) protocol. BMC Nephrol. 2018 Sep 12;19(1):230. doi: 10.1186/s12882-018-1032-0.