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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK133509-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtually supervised exercise | Behavioral | Participants will participate twice weekly in an live exercise program that they will access through a computer connected to the Internet. |
| 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 |
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Inclusion Criteria:
≥ 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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
Individual participant data that underlie the main results will be made available after deidentification.
Data will be available beginning 9 months after publication of the main study results. No end date.
To gain access, data requestors will need to provide a methodologically sound proposal of the planned research and sign a data use agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2026 | Jul 4, 2026 | ICF_000.pdf |
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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.
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| Health education | Behavioral | 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. |
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