Virtually Supervised Exercise for Kidney Transplant Candidates

Physical Disability Clinical Trial

Official title:

Virtually Supervised Exercise for Kidney Transplant Candidates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355545
• Other study ID #: 65020
• Secondary ID: 1R01DK133509-01
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Disability

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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