Hematopoietic and Lymphoid Cell NeoplasmNCT04968119
Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant
A study testing Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age at the time of study enrollment
- >= 2-years from hematopoietic cell transplantation (HCT) and in clinical remission
- Identified as pre-frail or frail based on Bone Marrow Transplant Survivorship Study (BMTSS) questionnaire (i.e. clinically underweight, exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of >= 3/5 indices classified as frail and 2/5 indices classified as prefrail
- Able to understand and sign the informed consent document
- Physically able and willing to complete all study procedures
- Has access to the internet and a smartphone
- English speaking
Who cannot join
- Overt cardiovascular disease (e.g. myocardial infarction, stroke, angina)
- Contraindications to exercise (acute infectious disease, physical disability preventing safe performance [assistive devices], cognitive impairment or inability to cooperate)
- Participation in regular exercise (> 60 minutes per week)
- Female who are pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of the telehealth exercise program, as evaluated by participation and completion rates.
SECONDARY OBJECTIVE:
- 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.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participate in telehealth exercise sessions
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| 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. Receives: Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 9
Secondary outcomes (3)
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.
Measured: From baseline to week 9
Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed
Physical functioning (Gait speed ) will be measured in the unit of time as seconds.
Measured: 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.
Measured: From baseline to week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start12 Jul 2021
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kyuwan Lee, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968119
- Sponsor's protocol ID
- 20731
- Other IDs
- NCI-2021-03539, 20731, P30CA033572
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37127595
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04968119
- Acronym / sponsor ID
- 20731
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 20 Jul 2021 (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 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.
Detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility of the telehealth exercise program, as evaluated by participation and completion rates.
SECONDARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (telehealth intervention) | Experimental | Other: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (delayed exercise intervention) | Active comparator | Other: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >= 18 years of age at the time of study enrollment
- >= 2-years from hematopoietic cell transplantation (HCT) and in clinical remission
- Identified as pre-frail or frail based on Bone Marrow Transplant Survivorship Study (BMTSS) questionnaire (i.e. clinically underweight, exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of >= 3/5 indices classified as frail and 2/5 indices classified as prefrail
- Able to understand and sign the informed consent document
- Physically able and willing to complete all study procedures
Key exclusion criteria (4 listed)
- Overt cardiovascular disease (e.g. myocardial infarction, stroke, angina)
- Contraindications to exercise (acute infectious disease, physical disability preventing safe performance [assistive devices], cognitive impairment or inability to cooperate)
- Participation in regular exercise (> 60 minutes per week)
- Female who are pregnant or planning to become pregnant
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 |
|---|---|---|
| Exercise InterventionParticipate in telehealth exercise sessions | Other | Arm A (telehealth intervention), Arm B (delayed exercise intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (telehealth intervention), Arm B (delayed exercise intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (telehealth intervention), Arm B (delayed exercise intervention) |
Primary outcome
Participation rate
Time frame: Week 9
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.
Intervention completion rate
Time frame: Week 9
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.
3 secondary outcomes
Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance
Time frame: From baseline to week 9
Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed
Time frame: From baseline to week 9
Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand
Time frame: From baseline to week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 37127595Lee 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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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.
Kyuwan Lee principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participation rate (time frame: Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968119, which also lists 1 linked publication.
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 6 Feb 2025.