Multiple Myeloma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Myeloma

Estimated Enrollment:

33

Study ID:

NCT05142371

Recruitment Status:

Active, not recruiting

Sponsor:

City of Hope Medical Center

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There is 1 Location for this study

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

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

33

Study ID:

NCT05142371

Recruitment Status:

Active, not recruiting

Sponsor:


City of Hope Medical Center

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