RESIST-ADT (Androgen Deprivation Therapy)
Preventing a Decline in Physical Function in Older Androgen-Deprived Men With Structured Exercise Training (RESIST-ADT Trial)
2 other identifiers
interventional
21
1 country
2
Brief Summary
The overall goal of this study is to determine if implementing structured exercises prevent decline in muscle mass, muscle strength and physical function in men with prostate cancer undergoing androgen deprivation therapy (ADT). Our main hypothesis is that structured resistance exercise training in men undergoing ADT will preserve physical function assessed by loaded stair climbing power compared with the control group. The trial will also examine the efficacy of the exercise regimen on muscle strength, QOL and fatigue. The findings of this trial will lay the groundwork for definitive intervention trials to prevent frailty and falls in these men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Dec 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedAugust 20, 2024
August 1, 2024
2.8 years
July 22, 2020
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Loaded stair climb power
Compare the efficacy of a structured resistance exercise regimen vs a structured control regimen on loaded stair climb power. Assessment of physical function as measured by Loaded Stair Climbing Power.
6 months
Secondary Outcomes (4)
Body composition
6 months
Muscle strength and power
6 months
Quality of Life (QOL)
6 months
Fatigue
6 months
Study Arms (2)
Progressive Resistance Training Exercise
EXPERIMENTALMen with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend structured progressive resistance exercise training sessions 2 times/week for six months.
Flexibility and Balance Exercise
ACTIVE COMPARATORMen with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend flexibility and balance exercises training sessions 2 times/week for six months.
Interventions
Progressive Resistance Training Exercise 2x weekly for 6 months.
Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.
Eligibility Criteria
You may qualify if:
- Men with active Prostate Cancer who are 60 years or older.
- Hormone-naive men about to undergo medical or surgical ADT.
- Planned ADT for at least 6 months.
- Life expectancy of at least 6 months from enrollment.
- Ability and willingness to provide informed consent.
You may not qualify if:
- Active medical conditions affecting participation in exercise training (limiting arthropathies, myopathies, severe peripheral vascular disease, or severe neuropathy).
- Cardiovascular disease (current angina, severe valvular disease, advanced congestive heart failure, arrhythmias, or stroke with residual muscular weakness).
- Prior hip or knee replacement.
- History of lower extremity fracture in the past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Institute on Aging (NIA)collaborator
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02066, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PMID: 39606939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shehzad Basaria, MD
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Thomas Storer, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants, Investigators and Research Staff will remain blinded. Only exercise personnel and study statistician will be unblinded.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 24, 2020
Study Start
December 1, 2020
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
August 20, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.