Recruiting

Prehabilitation

Sponsor:

Noha Mohamed Sharafeldin

Code:

NCT05642884

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Multi-modal Exercise Regimen

Dietary Guidelines

Study Details

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

Study ID

NCT05642884

Start date

Jul 10, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

other: 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..

Interventions

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.

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 measure

  • Participation rate [ Time Frame: 1 year ]
  • Completion rate [ Time Frame: 1 year ]
  • Adherence rate [ Time Frame: 1 year ]
  • Acceptability [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Landon Martin, BS

205-638-2120landoncmartin@uabmc.edu

Noha Sharafeldin, MBBS PhD MSc

2056382120nsharafeldin@uabmc.edu

Locations

Kirklin Clinic of UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Landon Martin, BS

(205) 638-2120CAREheme@peds.uab.edu

Principal Investigator:

Noha Sharafeldin

More Information

Sponsor

Noha Mohamed Sharafeldin

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Autologous Stem Cell Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Noha Mohamed Sharafeldin on 2025-12-24.