Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04968119
• Other study ID #: 20731
• Secondary ID: NCI-2021-0353920
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Other:
• Exercise Intervention
Participate in telehealth exercise sessions
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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.	From baseline to week 9
Secondary	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