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Completed

NCT Number: NCT04968119

Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Participate in telehealth exercise sessions

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance

    Time frame: From baseline to week 9

    Physical functioning (Timed balance) will be measured in the unit of time as seconds.

  2. Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed

    Time frame: From baseline to week 9

    Physical functioning (Gait speed ) will be measured in the unit of time as seconds.

  3. Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand

    Time frame: From baseline to week 9

    Physical functioning (Chair stand ) will be measured in the unit of time as seconds.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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