Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-modal Exercise Regimen, Dietary Guidelines.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant
Overview
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
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.
Interventions
- Other 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. - Behavioral 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 measures
- Participation rate [Time frame: 1 year]
- Completion rate [Time frame: 1 year]
- Adherence rate [Time frame: 1 year]
- Acceptability [Time frame: 1 year]
Secondary outcome measures (4)
- Change in Lower Extremity Physical Function [Time frame: 1 year]
- Change in Functional Exercise Capacity [Time frame: 1 year]
- Change in mobility [Time frame: 1 year]
- Change in functional status [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Kirklin Clinic of UAB Hospital — Birmingham
Identifiers
NCT: NCT05642884 · UAB 2281 · O'Neal Invests