Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

NCT04968119 | Completed DMC

• 3 other identifiers: 20731NCI-2021-03539P30CA033572
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

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

  From baseline to week 9

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

  From baseline to week 9

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

  From baseline to week 9

Study Arms (2)

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).

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.

Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Exercise Intervention OTHER

Participate in telehealth exercise sessions

Arm A (telehealth intervention); Arm B (delayed exercise intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (telehealth intervention); Arm B (delayed exercise intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm A (telehealth intervention); Arm B (delayed exercise intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• 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.

  PMID: 37127595 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kyuwan Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 20, 2021
• Study Start: July 12, 2021
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

US (1)