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Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >= 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

Exclusion Criteria:

  • 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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (telehealth intervention)

Arm B (delayed exercise intervention)

Arm Description

Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions).

Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 11, 2021
Last Updated
September 21, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04968119
Brief Title
Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant
Official Title
A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (telehealth intervention)
Arm Type
Experimental
Arm Description
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 Title
Arm B (delayed exercise intervention)
Arm Type
Active Comparator
Arm Description
Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Participate in telehealth exercise sessions
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Participation rate
Description
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.
Time Frame
Week 9
Title
Intervention completion rate
Description
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.
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance
Description
Physical functioning (Timed balance) will be measured in the unit of time as seconds.
Time Frame
From baseline to week 9
Title
Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed
Description
Physical functioning (Gait speed ) will be measured in the unit of time as seconds.
Time Frame
From baseline to week 9
Title
Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand
Description
Physical functioning (Chair stand ) will be measured in the unit of time as seconds.
Time Frame
From baseline to week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >= 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuwan Lee
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

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