Exercise is Medicine for Patients With CKD

NCT03311763 | Completed

• 1 other identifier: IRB-43198
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Kidney Disease stage4; Chronic Kidney Disease Stage V; Physical Activity

Keywords

implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Six minute walk test (6MWT)

  measured at baseline, 8 weeks and 16 weeks post start of intervention.

• Handgrip

  measured at baseline, 8 weeks and 16 weeks post start of intervention.

• Health-related Quality of life using Medical Outcomes Short form 12

  measured at baseline, 8 weeks and 16 weeks post start of intervention.

Other Outcomes (3)

• 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.

• Physical activity self-efficacy questionnaire

  measured at baseline, 8 weeks and 16 weeks post start of intervention.

• Waist circumference

  measured at baseline, 8 weeks and 16 weeks post start of intervention.

Study Arms (2)

Counseling alone

ACTIVE COMPARATOR

Group 1: physical activity assessment, brief counseling session + physical activity wearable

Behavioral: Counseling and wearable device

Group exercise

EXPERIMENTAL

Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program (two, 1 hour classes/week for 8 weeks).

Behavioral: EIM Fitness Practitioners; Behavioral: Counseling and wearable device

Interventions

EIM Fitness Practitioners BEHAVIORAL

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.

Group exercise

Counseling and wearable device BEHAVIORAL

Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.

Counseling alone; Group exercise

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Stanford University: lead
• Emory University: collaborator
• Santa Clara Valley Medical Center: collaborator

Study Sites (2)

Santa Clara Valley Nephrology

San Jose, California, 95128, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 34939004 BACKGROUND

• 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.

  PMID: 30208854 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Counseling; Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 17, 2017
• Study Start: April 16, 2018
• Primary Completion: December 31, 2020
• Study Completion: November 30, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)