Physical DisabilityNCT05355545
Virtually Supervised Exercise for Kidney Transplant Candidates
A study testing Virtually supervised exercise and Health education in people with Physical Disability, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- Virtually supervised exercise and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Physical Disability
- Being tested
- Virtually supervised exercise, Health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually supervised exerciseBehavioural
Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet.
Health educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtually supervised exercise | Experimental | 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. Receives: Behavioral: Virtually supervised exercise |
| Health education | Active comparator | 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. Receives: Behavioral: Virtually supervised exercise; Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start18 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Liu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355545
- Sponsor's protocol ID
- 65020
- Other IDs
- 1R01DK133509-01
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the main results will be made available after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Supervised Exercise for Kidney Transplant Candidates
- ClinicalTrials.gov ID
- NCT05355545
- Acronym / sponsor ID
- 65020
- Conditions
- Physical Disability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtually supervised exercise | Experimental | Behavioral: Virtually supervised exerciseIn 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. |
| Health education | Active comparator | Behavioral: Virtually supervised exercise, Behavioral: Health educationIn 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 18 years old
- Listed for kidney transplant
- Positive answers (e.g. yes) to one of the following:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtually supervised exerciseParticipants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet. | Behavioural | Health education, Virtually supervised exercise |
| Health educationParticipants 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. | Behavioural | Health education |
Primary outcome
Change in performance on 30 second sit to stand test
Time frame: Baseline through week 12
Number of times that a person can stand up from a sitting position in 30 seconds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the main results will be made available after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually supervised exercise and Health education in people with Physical Disability, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on 30 second sit to stand test (time frame: Baseline through week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.