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

Not Applicable

Completed

• Conditions: Plasma Cell Myeloma
• Interventions: Other: Exercise Intervention; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05142371
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-06
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Primary Completion: 2025-03-28
• Study Completion: 2025-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (home-based exercise program)	Exercise Intervention	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 A (home-based exercise program)	Quality-of-Life Assessment	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 A (home-based exercise program)	Questionnaire Administration	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 (current activities)	Questionnaire Administration	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.
Arm B (current activities)	Quality-of-Life Assessment	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.
Arm B (current activities)	Best Practice	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.

Primary Outcome Measures

Name	Time	Method
Physical function	Up to 8 weeks	Assessed by the Short Physical Performance Battery (SPPB) test.

Secondary Outcome Measures

Name	Time	Method
Frailty index	Up to 8 weeks	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).

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States