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NCT Number: NCT05642884

Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Landon Martin, BS

CONTACT

[email protected]

(205) 638-2120

Noha Sharafeldin

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-modal Exercise Regimen

Other

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 Guidelines

Behavioral

Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Lower Extremity Physical Function

    Time frame: 1 year

    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

  2. Change in Functional Exercise Capacity

    Time frame: 1 year

    Investigators will measure functional exercise capacity using 6-minute walking distance (6MWD) and compare the difference in 6MWD before and after intervention

  3. Change in mobility

    Time frame: 1 year

    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

  4. Change in functional status

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Landon Martin, BS

CONTACT

[email protected]

205-638-2120

Noha Sharafeldin, MBBS PhD MSc

CONTACT

[email protected]

2056382120

Sponsors and collaborators

Lead sponsor

Noha Mohamed Sharafeldin

Other

Collaborators

  • O'Neal Comprehensive Cancer Center at UAB

Registry information

Official study title

Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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