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Clinical Trials/NCT05142371
NCT05142371
Completed
Not Applicable

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

City of Hope Medical Center1 site in 1 country33 target enrollmentOctober 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plasma Cell Myeloma
Sponsor
City of Hope Medical Center
Enrollment
33
Locations
1
Primary Endpoint
Physical function
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 6, 2021
End Date
March 28, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Physical function

Time Frame: Up to 8 weeks

Assessed by the Short Physical Performance Battery (SPPB) test.

Secondary Outcomes

  • Frailty index(Up to 8 weeks)

Study Sites (1)

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