Physical Activity Clinical Trial
— EIM-CKDOfficial title:
A Multi-center Exercise Intervention for Persons Transitioning to Dialysis Using the "Exercise is Medicine" Framework
Verified date | January 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 56 |
Est. completion date | November 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Santa Clara Valley Nephrology | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Emory University, Santa Clara Valley Medical Center |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20) | Questionnaire based CESD-2 scale will be used to measure depression | measured at baseline, 8 weeks and 16 weeks post start of intervention. | |
Other | Physical activity self-efficacy questionnaire | measured at baseline, 8 weeks and 16 weeks post start of intervention. | ||
Other | Waist circumference | measured at baseline, 8 weeks and 16 weeks post start of intervention. | ||
Primary | Differences in minutes of physical activity per week as measured by wearable device | 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 | measured at baseline, 8 weeks and 16 weeks post start of intervention. | |
Secondary | Six minute walk test (6MWT) | 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 | measured at baseline, 8 weeks and 16 weeks post start of intervention. | |
Secondary | Handgrip | 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 | measured at baseline, 8 weeks and 16 weeks post start of intervention. | |
Secondary | Health-related Quality of life using Medical Outcomes Short form 12 | 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 | measured at baseline, 8 weeks and 16 weeks post start of intervention. |
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