Virtually Supervised Exercise for Kidney Transplant Candidates

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05355545

Collaborator

(none)

Enrollment

Arms

53.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is examining whether a virtually supervised exercise program can improve physical function in persons who are awaiting kidney transplant. We will compare the results to a similar group of persons who receive a health education program.

Condition or Disease	Intervention/Treatment	Phase
Physical Disability	Behavioral: Virtually supervised exercise Behavioral: Health education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study uses a parallel group delayed intervention design. In the first half of the study (Weeks 0 to 12), the intervention arm will receive the virtually supervised exercise intervention, while the active comparator arm will receive the health education program. In the second half of the study (Weeks 13 to 24), the intervention arm will continue the virtually supervised exercise intervention, while the active comparator group will start the virtually supervised exercise intervention. The primary timepoint of interest will be at 12 weeks.This study uses a parallel group delayed intervention design. In the first half of the study (Weeks 0 to 12), the intervention arm will receive the virtually supervised exercise intervention, while the active comparator arm will receive the health education program. In the second half of the study (Weeks 13 to 24), the intervention arm will continue the virtually supervised exercise intervention, while the active comparator group will start the virtually supervised exercise intervention. The primary timepoint of interest will be at 12 weeks.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Virtually Supervised Exercise for Kidney Transplant Candidates

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtually supervised exercise In the first half of the study (weeks 0 to 12), participants will receive a virtually supervised exercise program. In the second half of the study (weeks 13 to 24), participant will continue to receive the virtually supervised exercise program.	Behavioral: Virtually supervised exercise Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.
Active Comparator: Health education In the first half of the study (weeks 0 to 12), participants will receive a health education program. In the second half of the study (weeks 13 to 24), participant will receive a the virtually supervised exercise program.	Behavioral: Virtually supervised exercise Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet. Behavioral: Health education Participants will first participate in a once weekly live health education class that they will access through a computer connected to the Internet. During the second half of the study, participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.

Arm

Intervention/Treatment

Experimental: Virtually supervised exercise

In the first half of the study (weeks 0 to 12), participants will receive a virtually supervised exercise program. In the second half of the study (weeks 13 to 24), participant will continue to receive the virtually supervised exercise program.

Behavioral: Virtually supervised exercise

Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.

Active Comparator: Health education

In the first half of the study (weeks 0 to 12), participants will receive a health education program. In the second half of the study (weeks 13 to 24), participant will receive a the virtually supervised exercise program.

Behavioral: Virtually supervised exercise

Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.

Behavioral: Health education

Participants will first participate in a once weekly live health education class that they will access through a computer connected to the Internet. During the second half of the study, participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.

Outcome Measures

Primary Outcome Measures

Change in performance on 30 second sit to stand test [Baseline through week 12]
Number of times that a person can stand up from a sitting position in 30 seconds

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Listed for kidney transplant

Exclusion Criteria:

Nursing home resident
Severe low vision (≥20/200 with corrective lens)
Severe hearing loss even with use of amplification preventing communication
Unstable angina or uncontrolled arrhythmia
Supplemental oxygen therapy
Inability to stand upright
Lack of fluency in English
Myocardial infarction, major heart surgery, stroke, venous thromboembolism, hip fracture, hip or knee replacement in past six months (temporary exclusion)
Current receipt of physical therapy (temporary exclusion)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christine Liu, Assistant Professor of Medicine, Stanford University

ClinicalTrials.gov Identifier:

NCT05355545

Other Study ID Numbers:

65020

First Posted:

May 2, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 2, 2022