Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-27 @ 12:23 PM
Study NCT ID:
NCT05706766
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2023-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes.
The names of the study interventions involved in this study are:
* Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program)
* Waitlist control (8-week normal activity behavior)
The names of the study interventions involved in this study are:
* Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program)
* Waitlist control (8-week normal activity behavior)
Detailed Description:
This is a single-center, prospective, parallel-group, randomized controlled study that will enroll patients diagnosed with multiple myeloma planning to receive autologous stem cell transplant (ASCT).
Participants will be randomized into one of the intervention groups: Exercise Group (PARE) versus Waitlist Control Group. Randomization means that participants are placed into one of the treatment groups by chance.
The research study procedures include screening for eligibility and study treatment including evaluations of muscle strength, cardiorespiratory fitness, physical fitness assessments, body composition including DEXA scans, blood tests, and surveys at study entry and follow-up visits.
Participation is expected to last about 4 months for the Exercise Group (PARE) and 9 months for the Waitlist Control Group.
It is expected about 30 people with take part in this research study.
Dana-Farber Cancer Institute is supporting this research study by providing funding through the Population Sciences Team Science Concept program.
Participants will be randomized into one of the intervention groups: Exercise Group (PARE) versus Waitlist Control Group. Randomization means that participants are placed into one of the treatment groups by chance.
The research study procedures include screening for eligibility and study treatment including evaluations of muscle strength, cardiorespiratory fitness, physical fitness assessments, body composition including DEXA scans, blood tests, and surveys at study entry and follow-up visits.
Participation is expected to last about 4 months for the Exercise Group (PARE) and 9 months for the Waitlist Control Group.
It is expected about 30 people with take part in this research study.
Dana-Farber Cancer Institute is supporting this research study by providing funding through the Population Sciences Team Science Concept program.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: