Virtually Supervised Exercise for Kidney Transplant Candidates

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Disability
• Intervention / Treatment: Behavioral: Virtually supervised exercise; Behavioral: Health education

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Christine Liu, MD; Phone Number: 650-723-1365; Email: kidneystudy@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Virtually supervised exercise; Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.
Active Comparator: 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.	Behavioral: Virtually supervised exercise; Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 65020; 1R01DK133509-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the main results will be made available after deidentification.
• IPD Sharing Time Frame: Data will be available beginning 9 months after publication of the main study results. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No