Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

NCT05642884 | Recruiting

• 2 other identifiers: UAB 2281O'Neal Invests
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Myeloma

Keywords

Autologous Stem Cell Transplant

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 year

Secondary Outcomes (4)

• Change in Lower Extremity Physical Function

  1 year

• Change in Functional Exercise Capacity

  1 year

• Change in mobility

  1 year

• Change in functional status

  1 year

Study Arms (2)

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.

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..

Behavioral: Dietary Guidelines

Interventions

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.

Teleprehab

Dietary Guidelines BEHAVIORAL

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

Attention Control; Teleprehab

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Multiple Myeloma
• Scheduled for ASCT at UAB within 10 weeks of study enrollment
• age at ASCT ≥60y

You may not qualify if:

• at high risk for impending pathologic fracture using Mirels score

Sponsors & Collaborators

• Noha Mohamed Sharafeldin: lead
• O'Neal Comprehensive Cancer Center at UAB: collaborator

Study Sites (1)

Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Nutrition Policy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Policy; Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Central Study Contacts

Landon Martin, BS

CONTACT

205-638-2120; landoncmartin@uabmc.edu

Noha Sharafeldin, MBBS PhD MSc

CONTACT

2056382120; nsharafeldin@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 8, 2022
• Study Start: July 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)