Virtually Supervised Exercise for Kidney Transplant Candidates

NCT ID: NCT05355545

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2026-07-07

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.

Detailed Description

This study is examining if a virtually supervised exercise program can improve physical function in persons awaiting kidney transplant. A double-blind, parallel group randomized controlled clinical trial, this study will enroll 80 persons for 24 weeks. Our primary outcome is performance on the 30 second sit to stand test, and our secondary outcomes are changes in the Fatigue Severity Scale and the Beck Depression Inventory.

Conditions

Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtually supervised exercise

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Virtually supervised exercise

Intervention Type: BEHAVIORAL

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

Health education

Intervention Type: 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.

Interventions

Virtually supervised exercise

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 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

Exclusion Criteria

• 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
• Myocardial infarction, major heart surgery, stroke, venous thromboembolism, hip fracture, hip or knee replacement in past six months (temporary exclusion)
• ≥ 3 errors on the Six Item Screener

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christine Liu

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine K Liu, MD

Role: CONTACT

kidneystudy@stanford.edu

650-723-1365

Facility Contacts

Christine Liu, MD

Role: primary

kidneystudy@stanford.edu

650 723 1365

Other Identifiers

1R01DK133509-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

65020

Identifier Type: -

Identifier Source: org_study_id