A Pilot Study to Assess Adherence of an Exercise Prescription in Elderly Multiple Myeloma Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Plasma Cell Myeloma
- Sponsor
- Thomas Jefferson University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Retention
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This trial studies how well exercise prescription works in improving quality of life in elderly patients with multiple myeloma. Engaging and adhering to an exercise program may improve functional status and quality of life and decrease pain and skeletal-related events. This study is being done to see if elderly patients with multiple myeloma can participate in a physical activity program.
Detailed Description
PRIMARY OBJECTIVE: I. Assess the ability for elderly multiple myeloma patients to maintain a personalized exercise regimen and activity level for a period of 6 months. SECONDARY OBJECTIVE: I. Assess changes in biometric data. EXPLORATORY OBJECTIVE I. Evaluate changes in bone metabolism markers as a result of exercise. OUTLINE: Patients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks. After completion of study, patients are followed up every 6 months for 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of multiple myeloma
- •If patients are undergoing an autologous stem cell transplant, then they will be enrolled after their transplant so that there is not an interruption in the study period
- •Patients are eligible whether or not they have lytic bone lesions
- •If they do have lytic lesions, the lesions must be low risk for fracture (low risk by Mirel's score or less than 50% of vertebral body height)
- •If patients are high risk for bone fracture, they must undergo bone stabilization prior to being considered for enrollment
- •Patients will have to be at least 6 weeks from date of stabilization
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Subjects need to be within 24 months of their multiple myeloma diagnosis
- •Subject must be able to stand and walk to perform baseline assessments
Exclusion Criteria
- •Presence of lytic lesions that cannot undergo appropriate stabilization
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
- •Non English speaking
- •Diagnosed greater than 24 months prior to screening
Outcomes
Primary Outcomes
Retention
Time Frame: Up to 6 months
Will be measured by percent number of days the patient wears the provided FitBit during the 6-month period.
Physical activity adherence
Time Frame: Up to 6 months
Will be measured at each assessment using an Actigraph tri-axial hip-worn accelerometers, worn for 7 days at each assessment point, supplemented with patient self-report of exercise in the past 7 days using a physical activity recall to differentiate subtypes of physical activity. Will estimate the proportion of participants who maintained their target level, along with an exact 95% confidence interval. We will use an exact binomial test to assess whether adherence exceeds 50%. Adherence to the exercise prescriptions will be measured with the absolute and relative increase from baseline in min/week of aerobic and resistance exercise at 3 months and 6 months (benchmark: min/week of exercise changes by \> 100% and a minimum of 90 min/week at 6 months). The percent of prescribed minutes of exercise performed at 3 and 6 months also will be calculated with goal of adherence greater than 50%.
Secondary Outcomes
- Change in grip strength(Baseline up to 6 months)
- Change in frailty score(Baseline up to 6 months)
- Change in 6 minute walk test(Baseline up to 6 months)
- Change in short physical performance battery protocol(Baseline up to 6 months)
- Change in Mini-Balance Evaluation Systems Test(Baseline up to 6 months)