Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors

Effects of an 8-Week Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors

This clinical trial examines a telehealth exercise intervention in improving physical function and frailty in multiple myeloma survivors. The exercise program uses a telehealth platform (delivered by smart phones, tablets, or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance, and resistance/aerobic (cardio) training. Frailty includes being underweight, slow walking speed, exhaustion, low physical activity, and weakness. Participating in an exercise program may help improve patient's physical function and strength.

Study Overview

• Status: Completed
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Exercise Intervention; Other: Questionnaire Administration; Other: Best Practice

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the effects of an 8-week telehealth exercise intervention on physical function as assessed by the Short Physical Performance Battery (SPPB) test (Aim 1)

SECONDARY OBJECTIVES:

I. Determine the effects of an 8-week telehealth exercise intervention as assessed using a 5-scale frailty index: body mass index (self-report), tiredness (questionnaire), level of physical activity (self-report), gait speed (sensors), and muscular strength (hand grip dynamometer) (Aim 2).

II. Determine the sustainability of the intervention on physical function and frailty at week 17 (Aim 3).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo home-based exercise program 3 times per week for 8 weeks. Patients complete questionnaires at baseline (before 1 week) and at weeks 9 and 17.

ARM B: Patients complete questionnaires at baseline and at week 9 and 17. Patients continue maintaining current activities of daily living and do not participate in any exercise program. Patients may then participate in home-based exercise program 3 times per week for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with multiple myeloma
• >= 18 years old
• Self-reported as pre-frail or frail (i.e. Fried Criteria: clinically underweight and exhibiting exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of 2/5 indices classified as pre-frail and >= 3/5 indices classified as frail
• Has undergone autologous stem cell transplant (ASCT) within 30 and 180 days prior to registration
• Physically able and willing to complete all study procedures
• English-speaking

Exclusion Criteria:

• Have clinically significant/active cardiovascular disease (e.g. unstable angina, uncontrolled arrhythmia, etc.)
• Have contraindications to exercise (acute infectious disease or unstable bone lesions)
• Currently recovering from a recent injury or have been physically injured in the past 6 months, in which participation in rigorous exercise may not be appropriate
• Participate in regular, structured exercise (> 60 minutes/week)
• Female patients who are pregnant or planning to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (home-based exercise program); Patients undergo home-based exercise program 3 times per week for 8 weeks. Patients complete questionnaires at baseline (before 1 week) and at weeks 9 and 17.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Exercise Intervention; Participate in exercise intervention; Other: Questionnaire Administration; Complete questionnaires
Active Comparator: Arm B (current activities); Patients complete questionnaires at baseline and at week 9 and 17. Patients continue maintaining current activities of daily living and do not participate in any exercise program. Patients may then participate in home-based exercise program 3 times per week for 8 weeks.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete questionnaires; Other: Best Practice; Continue current activities of daily living; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Assessed by the Short Physical Performance Battery (SPPB) test.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty index	Assessed using a 5-scale frailty index: body mass index (self-report), tiredness (questionnaire), level of physical activity (self-report), gait speed (sensors), and muscular strength (hand grip dynamometer).	Up to 8 weeks

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kyuwan Lee, City of Hope Comprehensive Cancer Center

Publications and helpful links

General Publications

• Lee K, Nathwani N, Shamunee J, Lindenfeld L, Wong FL, Krishnan A, Armenian S. Telehealth exercise to Improve Physical function and frailty in patients with multiple myeloma treated with autologous hematopoietic Stem cell transplantation (TIPS): protocol of a randomized controlled trial. Trials. 2022 Nov 3;23(1):921. doi: 10.1186/s13063-022-06848-y.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Frailty; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 21406 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2021-11000 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request, beginning 9 months and ending 36 months following article publication
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publicatio
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.; For individual participant data meta-analysis; Proposal may be submitted up to 36 months following article publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• 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