Virtually Supervised Exercise for Kidney Transplant Candidates

Not Applicable

Recruiting

• Conditions: Physical Disability
• Interventions: Behavioral: Virtually supervised exercise; Behavioral: Health education

• Registration Number: NCT05355545
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-02
• Study Start: 2023-12-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-13
• Last Update Posted: 2024-07-16
• Primary Completion: 2026-07-07
• Study Completion: 2026-07-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• Does not speak English
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health education	Virtually supervised exercise	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.
Health education	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.
Virtually supervised exercise	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States