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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03539 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20731 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies the feasibility of implementing a telehealth exercise platform to reduce frailty in patients after bone marrow transplant.
The exercise program uses a telehealth platform (e.g. smart phones, tablets or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance and resistance/aerobic training.
Physical activity may help to improve physical function, including frailty, after bone marrow transplant. Information from this trial may help researchers design future telehealth exercise routines for treating people with cancer.
PRIMARY OBJECTIVE:
I. Determine the feasibility of the telehealth exercise program, as evaluated by participation and completion rates.
SECONDARY OBJECTIVE:
I. Explore the effects of the telehealth exercise program on physical functioning.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions).
ARM B: Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (telehealth intervention) | Experimental | Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions). |
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| Arm B (delayed exercise intervention) | Active Comparator | Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Participate in telehealth exercise sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Participation rate | Rate of participation is defined as number of hematopoietic cell transplantation (HCT) survivors who were approached and participated divided by the total number of eligible HCT survivors who were approached for the study and then multiplied by 100%. Will be considered feasible if >= 50% of eligible patients that are approached for participation enroll onto the study. Minimal descriptive statistical analyses will be performed for all participant baseline characteristics and compared across groups to test for balance across the groups, using t-tests (or non-parametric Wilcoxon rank sum) for continuous variables and chi-square tests for categorical variables. | Week 9 |
| Intervention completion rate | Will be considered feasible if >= 75% of enrolled participants successfully complete all study measurements (remote physical function) and > 50% of patients randomized to the intervention arm are able to complete > 70% of total exercise sessions (17/24 sessions). Minimal descriptive statistical analyses will be performed for all participant baseline characteristics and compared across groups to test for balance across the groups, using t-tests (or non-parametric Wilcoxon rank sum) for continuous variables and chi square tests for categorical variables. | Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance | Physical functioning (Timed balance) will be measured in the unit of time as seconds. | From baseline to week 9 |
| Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyuwan Lee | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37127595 | Derived | Lee K, Shamunee J, Lindenfeld L, Ross E, Hageman L, Sedrak MS, Wong FL, Nakamura R, Forman SJ, Bhatia S, Armenian SH. Feasibility of implementing a supervised telehealth exercise intervention in frail survivors of hematopoietic cell transplantation: a pilot randomized trial. BMC Cancer. 2023 May 1;23(1):390. doi: 10.1186/s12885-023-10884-5. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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Physical functioning (Gait speed ) will be measured in the unit of time as seconds. |
| From baseline to week 9 |
| Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand | Physical functioning (Chair stand ) will be measured in the unit of time as seconds. | From baseline to week 9 |