Strength Training for ARthritis Trial
START
2 other identifiers
interventional
377
1 country
1
Brief Summary
The primary purpose of this study is to compare the effects of a high and low intensity strength training programs vs. a control group on knee pain and compressive joint forces.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Mar 2012
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
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
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 9, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedApril 20, 2020
October 1, 2017
6.4 years
November 22, 2011
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
WOMAC Pain
To determine if an 18-month, high-intensity strength-training intervention significantly decreases pain relative to low-intensity strength training and attention control groups. The pain index assesses participants' pain on a scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Baseline, 18 months
Knee Compressive Forces
To compare the effects of 18 months of high-intensity strength training, low-intensity strength training, and attention control on knee-joint compressive forces during walking.
Baseline, 18 Months
Secondary Outcomes (10)
WOMAC Pain
Baseline, 6 months
WOMAC Function
Baseline, 6 months
Mobility
Baseline, 6 months
Knee Compressive Forces
Baseline, 6 months
WOMAC Function
Baseline, 18 Months
- +5 more secondary outcomes
Study Arms (3)
High Intensity Strength Training
EXPERIMENTALThe strength-training intervention will consist of 5-min warm-up, 40-min training, and 15-min cool-down. The 60-min sessions will be conducted 3 times/wk for 18 months. Every 2 weeks the load lifted will be adjusted so that the participants in this group are lifting 3 sets of each exercise at 75-90% of 1RM.
Low Intensity Strength Training
EXPERIMENTALThe strength-training intervention will consist of 5-min warm-up, 40-min training, and 15-min cool-down. The 60-min sessions will be conducted 3 times/wk for 18 months. Every 2 weeks the load lifted will be adjusted so that the participants are lifting 3 sets of 15 repetitions at 30-40% of 1RM.
Attention Control
ACTIVE COMPARATORParticipants in the control group will attend 60-min organized workshops 2 times/month for the first 6 months and then 1 time/month for months 7-18. Over the 18 months interactive presentations will cover such topics as foot care, nutrition, managing medication, and sleep practices, and experts will give wide-ranging lectures.
Interventions
The strength-training intervention will consist of 5-min warm-up, 40-min training, and 15-min cool-down. The 60-min sessions will be conducted 3 times/wk for 18 months. Every 2 weeks the load lifted will be adjusted so that the participants in this group are lifting 3 sets of each exercise at 75-90% of 1RM.
The strength-training intervention will consist of 5-min warm-up, 40-min training, and 15-min cool-down. The 60-min sessions will be conducted 3 times/wk for 18 months. Every 2 weeks the load lifted will be adjusted so that the participants are lifting 3 sets of 15 repetitions at 30-40% of 1RM.
Participants in the control group will attend 60-min organized workshops 2 times/month for the first 6 months and then 1 time/month for months 7-18. Over the 18 months interactive presentations will cover such topics as foot care, nutrition, managing medication, and sleep practices, and experts will give wide-ranging lectures.
Eligibility Criteria
You may qualify if:
- Mild to Moderate Knee Osteoarthritis
You may not qualify if:
- BMI \<20 kg/m2 and ≥45 kg/m2
- Knee varus malalignment
- Participation in formal strength training for more than 30 min/week in the past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University
Winston-Salem, North Carolina, 27109, United States
Related Publications (2)
Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.
PMID: 33591346DERIVEDMessier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Williamson JD, Bennell KL, Guermazi A, Lyles M, Loeser RF. Strength Training for Arthritis Trial (START): design and rationale. BMC Musculoskelet Disord. 2013 Jul 15;14:208. doi: 10.1186/1471-2474-14-208.
PMID: 23855596DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen P Messier, PhD
Wake Forest University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2011
First Posted
December 9, 2011
Study Start
March 1, 2012
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
April 20, 2020
Record last verified: 2017-10