Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

Noha Mohamed Sharafeldin

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Other: Multi-modal Exercise Regimen; Behavioral: Dietary Guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT05642884

UAB 2281

O'Neal Invests (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Teleprehab

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary Guidelines

Other: Multi-modal Exercise Regimen

Attention Control

Other group

Description:

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..

Treatment:

Behavioral: Dietary Guidelines