Plasma Cell Myeloma
Conditions
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.
Interventions
OTHERBest Practice
Continue current activities of daily living
OTHERExercise Intervention
Participate in exercise intervention
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical function | Up to 8 weeks | Assessed by the Short Physical Performance Battery (SPPB) test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed