Multiple MyelomaNCT05642884
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
A study testing Multi-modal Exercise Regimen and Dietary Guidelines in people with Multiple Myeloma, run by Noha Mohamed Sharafeldin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Multi-modal Exercise Regimen and Dietary Guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple Myeloma
- Scheduled for ASCT at UAB within 10 weeks of study enrollment
- age at ASCT ≥60y
Who cannot join
- at high risk for impending pathologic fracture using Mirels score
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35294
Landon Martin, BS, (205) 638-2120, CAREheme@peds.uab.edu
Noha Sharafeldin
About this study
Official title: Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant
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.
Read the detailed description
This is a pilot randomized trial of older adults 60y and above planned to undergo Autologous Stem Cell Transplant for Multiple Myeloma. Eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). Assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. Investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.
- Conditions
- Multiple Myeloma
- Being tested
- Multi-modal Exercise Regimen, Dietary Guidelines
- Keywords
- Autologous Stem Cell Transplant
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal Exercise RegimenOther
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.
Dietary GuidelinesBehavioural
Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.
| Study group | Role | What they receive |
|---|---|---|
| Teleprehab | Experimental | The participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions. Receives: Other: Multi-modal Exercise Regimen; Behavioral: Dietary Guidelines |
| Attention Control | Other | The participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week.. Receives: Behavioral: Dietary Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Participation rate will be measured as the number of participants agreeing to participate in the study divided by total participants approached for the study.
Measured: 1 year
Completion rate
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.
Measured: 1 year
Adherence rate
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.
Measured: 1 year
Acceptability
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.
Measured: 1 year
Secondary outcomes (4)
Change in Lower Extremity Physical Function
Investigators will measure lower extremity physical function using the Short Physical Performance Battery Scores (SPPB, score 0-12; higher score indicates better physical function) and compare the difference in SPPB scores before and after intervention
Measured: 1 year
Change in Functional Exercise Capacity
Investigators will measure functional exercise capacity using 6-minute walking distance (6MWD) and compare the difference in 6MWD before and after intervention
Measured: 1 year
Change in mobility
Investigators will measure mobility of study participants using the 9-item life space questionnaire (LSQ; score range 0-120, higher scores indicate better mobility) and compare the difference in LSQ before and after intervention
Measured: 1 year
Change in functional status
Investigators will measure functional status using the Older Americans Resources and Services (OARS) Activities of Daily Living and Instrumental Activities of Daily Living (ADL/IADL) compare the difference in ADL/IADL scores before and after intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start10 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We plan to enroll a total of 30 patients, randomized 1:1 using permuted block algorithm stratified by sex and age (e.g. 60-70, \>70y), into intervention arm (home based prehabilitation) vs an attention control (dietary counseling) group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Mohamed Sharafeldin
- Sponsor type
- University, hospital or other
- Collaborators
- O'Neal Comprehensive Cancer Center at UAB
- Responsible party
- Sponsor-investigator, Noha Mohamed Sharafeldin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642884
- Sponsor's protocol ID
- UAB 2281
- Other IDs
- O'Neal Invests
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05642884
- Acronym / sponsor ID
- UAB 2281
- Conditions
- Multiple Myeloma
- Keywords
- Autologous Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Noha Mohamed SharafeldinUniversity, hospital or other
- Collaborators
- O'Neal Comprehensive Cancer Center at UAB
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot randomized trial of older adults 60y and above planned to undergo Autologous Stem Cell Transplant for Multiple Myeloma. Eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). Assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. Investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We plan to enroll a total of 30 patients, randomized 1:1 using permuted block algorithm stratified by sex and age (e.g. 60-70, >70y), into intervention arm (home based prehabilitation) vs an attention control (dietary counseling) group.
| Arm | Type | Receives |
|---|---|---|
| Teleprehab | Experimental | Other: Multi-modal Exercise Regimen, Behavioral: Dietary GuidelinesThe participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions. |
| Attention Control | Other | Behavioral: Dietary GuidelinesThe participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week.. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Multiple Myeloma
- Scheduled for ASCT at UAB within 10 weeks of study enrollment
- age at ASCT ≥60y
Key exclusion criteria (1 listed)
- at high risk for impending pathologic fracture using Mirels score
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal Exercise RegimenParticipants 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. | Other | Teleprehab |
| Dietary GuidelinesParticipants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors. | Behavioural | Attention Control, Teleprehab |
Primary outcome
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.
4 secondary outcomes
Change in Lower Extremity Physical Function
Time frame: 1 year
Change in Functional Exercise Capacity
Time frame: 1 year
Change in mobility
Time frame: 1 year
Change in functional status
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal Exercise Regimen and Dietary Guidelines in people with Multiple Myeloma, run by Noha Mohamed Sharafeldin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Landon Martin, BS (205-638-2120, landoncmartin@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.