Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes.
The names of the study interventions involved in this study are:
* Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program) * Waitlist control (8-week normal activity behavior)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years old.
All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant team, and assigned to the autologous transplantation waiting list for a first transplant.
Planning to receive autologous stem cell transplant after 8 weeks with or without concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
Medical clearance to perform moderate-vigorous intensity aerobic and resistance exercise intervention and fitness testing by their treating physician or a certified clinical exercise physiologist.
Disqualifiers
History of unstable angina, abnormal resting ECG and/or unstable angina or a heart attack in the previous month to allow safe completion of the cardiopulmonary exercise test (CPET) or VO2peak test.
Patients with known spinal instability, spinal cord compression or neurological deficits or contraindications that preclude exercise.
Those who have had recent (within six weeks) spinal surgery or other intervention surgery for pathological fractures.
Those deemed unsuitable to partake by the transplant or study team.
Trial design
Design model
Parallel
Treatments tested in this trial
PARE
BehavioralAerobic and resistance exercise program via Zoom platform.
Waitlist Control Group
BehavioralNormal Activities.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Exercise Group (PARE)Experimental treatment 1 intervention
Group B: Waitlist Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in Muscular Strength
The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.
Time frame
Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)Secondary outcomes
1
Difference in Physical Capacity
Physical capacity includes physical function and cardiorespiratory fitness which are measured through the Short Physical Performance Battery (SPPB) protocol and a maximal oxygen uptake (VO2 max) test, respectively. Differences in physical capacity across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Time frame
up to 9 months2
Difference in Patient Reported Outcomes
Patient reported outcomes, including fatigue and quality of life, are assessed through validated questionnaires. Differences in patient reported outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Time frame
up to 9 months3
Difference in Cardiometabolic Health Outcomes
Cardiometabolic health outcomes, including biomarkers of metabolic syndrome and body composition will be assessed through blood draws and dual-energy X-ray absorptiometry (DEXA), validated and safe measures. Differences in cardiometabolic health outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.
Time frame
up to 9 monthsSponsors and contacts
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Source ClinicalTrials.gov