Clinical trial NCT05355545: Virtually Supervised Exercise for Kidney Transplant Candidates
Official title: Virtually Supervised Exercise for Kidney Transplant Candidates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Disability
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in performance on 30 second sit to stand test
timeFrame: Baseline through week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: