Virtually Supervised Exercise for Kidney Transplant Candidates

Stanford University

Status: Enrolling

Conditions: Physical Disability

Treatments: Behavioral: Health education; Behavioral: Virtually supervised exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05355545

65020

1R01DK133509-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Virtually supervised exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Virtually supervised exercise

Health education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Virtually supervised exercise

Behavioral: Health education