NCT05642884 · Noha Mohamed Sharafeldin
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
What this study is about
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomly assigned into either a prehabilitation program or an attention control group before their transplant.
View original scientific description
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.
Interventions
OTHER
Multi-modal Exercise Regimen
Participants will undergo a total of 16 sessions over 8 weeks. Each therapy session will comprise of patient education, including facilitated goal planning, promotion of physical activity and safe exercise guideline, followed by 30 minutes of preferred aerobic activity such as walking or biking.
BEHAVIORAL
Dietary Guidelines
Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.
Primary outcome measures
Participation rate
Time frame: 1 year
Participation rate will be measured as the number of participants agreeing to participate in the study divided by total participants approached for the study.
Completion rate
Time frame: 1 year
Completion rate will be measured as the number of participants completing the study intervention phase (8 weeks) divided by the total number of participants starting the intervention.
Adherence rate
Time frame: 1 year
Adherence rate will be computed Number of participants attending at least 80% of the planned intervention sessions divided by the total number of participants initiating the intervention.
Acceptability
Time frame: 1 year
Acceptability of intervention will be measured using a) 9-item Theoretical Framework of Acceptability Questionnaire which measures participants perspectives on the acceptability of the study intervention. Responses are measured in a likert type scale. and b) a semi-structured interview that will be focused on gathering overall acceptability of the intervention to the participants. Interview questions will be focused on understanding participants perspectives using 7 different proposed constructs of acceptability, i.e affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self efficacy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of Multiple Myeloma
- Scheduled for ASCT at UAB within 10 weeks of study enrollment
- age at ASCT ≥60y
Exclusion criteria
- at high risk for impending pathologic fracture using Mirels score
Where
- Birmingham, Alabama
Collaborators
O'Neal Comprehensive Cancer Center at UAB
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations