Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

NCT ID: NCT05642884

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Multiple Myeloma

Keywords

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Autologous Stem Cell Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Teleprehab

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.

Group Type EXPERIMENTAL

Multi-modal Exercise Regimen

Intervention Type 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

Intervention Type BEHAVIORAL

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

Attention Control

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..

Group Type OTHER

Dietary Guidelines

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type OTHER

Dietary Guidelines

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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O'Neal Comprehensive Cancer Center at UAB

UNKNOWN

Sponsor Role collaborator

Noha Mohamed Sharafeldin

OTHER

Sponsor Role lead

Responsible Party

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Noha Mohamed Sharafeldin

Principal Investigator; Assistant Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Landon Martin, BS

Role: CONTACT

Phone: 205-638-2120

Email: [email protected]

Noha Sharafeldin, MBBS PhD MSc

Role: CONTACT

Phone: 2056382120

Email: [email protected]

Facility Contacts

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Landon Martin, BS

Role: primary

Other Identifiers

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O'Neal Invests

Identifier Type: OTHER

Identifier Source: secondary_id

UAB 2281

Identifier Type: -

Identifier Source: org_study_id