Virtually Supervised Exercise for Kidney Transplant Candidates

NCT05355545 | Active Not Recruiting DMC

• 2 other identifiers: 650201R01DK133509-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Disability

Outcome Measures

Primary Outcomes (1)

• Change in performance on 30 second sit to stand test

  Number of times that a person can stand up from a sitting position in 30 seconds

  Baseline through week 12

Study Arms (2)

Virtually supervised exercise

EXPERIMENTAL

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

Health education

ACTIVE COMPARATOR

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; Behavioral: Health education

Interventions

Virtually supervised exercise BEHAVIORAL

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

Health education; Virtually supervised exercise

Health education BEHAVIORAL

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.

Health education

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Listed for kidney transplant
• Positive answers (e.g. yes) to one of the following:
• current difficulty with climbing up 10 stairs,
• has changed in the past year how they climb 10 stairs
• current difficulty with walking a 0.5 mile (5-6 blocks)
• has changed in past year in how they walk 0.5 mile (5-6 blocks)
• documented performance of 430 meters or less on the six minute walk test in the past 12 months
• documented performance of 9 points or less on the Short Physical Performance Battery in the past 24 months
• documented performance of less than 3 points or less on the five times sit to stand test in the past 24 months
• Demonstrated ability to stand up independently from a seated position and then sit back down without using their arms or an assistive device in the past 24 months

You may not qualify if:

• Does not speak English or Spanish
• 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
• ≥ 3 errors on the Six Item Screener

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 2, 2022
• Study Start: December 18, 2023
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available beginning 9 months after publication of the main study results. No end date.
• Access Criteria: To gain access, data requestors will need to provide a methodologically sound proposal of the planned research and sign a data use agreement.

Locations

US (1)