Strength Training for ARthritis Trial (START)

• ClinicalTrials.gov Identifier: NCT01489462
• Recruitment Status: Completed
• First Posted: December 9, 2011
• Last Update Posted: November 6, 2017
• Sponsor: Wake Forest University
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information

• First Submitted Date: November 22, 2011
• First Posted Date: December 9, 2011
• Last Update Posted Date: November 6, 2017
• Study Start Date: March 2012
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2015)

Pain [ Time Frame: Baseline, 6 months, 12 months, 18 months ]

The investigators will measure short term (6 months) and long term (12 and 18 months) changes in pain.

Original Primary Outcome Measures (submitted: December 8, 2011)

• Pain [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
  The investigators will measure short term (6 months) and long term (12 and 18 months) changes in pain.
• Knee Joint Compressive Forces [ Time Frame: Baseline, 6 months, 18 months ]
  The investigators will measure short term (6 months) and long term (18 months) changes in compressive forces.

• Change History: Complete list of historical versions of study NCT01489462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 1, 2015)

• Knee Compressive Forces [ Time Frame: Baseline, 6 Months, 18 Months ]
  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.
• Function [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months ]
  The investigators will measure short term (6 months) and long term (12 and 18 months) changes in function.
• Mobility [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months ]
  The investigators will measure short term (6 months) and long term (12 and 18 months) changes in mobility.
• Inflammatory Markers [ Time Frame: Baseline, 6 Months, 18 Months ]
  The investigators will measure short term (6 months) and long term (18 months) changes in inflammatory markers.
• Thigh Composition [ Time Frame: Baseline, 18 Months ]
  The investigators will measure short term (6 months) and long term (18 months) changes in thigh composition.

Original Secondary Outcome Measures (submitted: December 8, 2011)

• Function [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months ]
  The investigators will measure short term (6 months) and long term (12 and 18 months) changes in function.
• Mobility [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months ]
  The investigators will measure short term (6 months) and long term (12 and 18 months) changes in mobility.
• Inflammatory Markers [ Time Frame: Baseline, 6 Months, 18 Months ]
  The investigators will measure short term (6 months) and long term (18 months) changes in inflammatory markers.
• Thigh Composition [ Time Frame: Baseline, 18 Months ]
  The investigators will measure short term (6 months) and long term (18 months) changes in thigh composition.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Strength Training for ARthritis Trial
• Official Title: Strength Training for ARthritis Trial
• 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.

Detailed Description

Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with knee osteoarthritis (OA), and thigh muscle weakness is an independent and modifiable risk factor for it. However, while all published treatment guidelines, supported by Level-1 evidence, recommend muscle strengthening to combat sarcopenia and improve muscle quality in knee OA patients, previous strength-training studies either used intensities or loads below recommended levels or were generally short, lasting only 6 to 24 weeks. Consequently, they had low-to-modest effect sizes, could not detect changes in disease progression, did not address underlying OA mechanisms, and provided little lasting clinical benefit. The positive effects of long-term, structured exercise are known to persist even years after supervised treatment terminates.

The efficacy of high intensity strength training in improving OA symptoms, slowing progression, and affecting the underlying mechanisms has not been examined due to the unsubstantiated belief that it might exacerbate symptoms. Our preliminary data clearly show excellent tolerance for high-intensity strength training as well as reduced pain and increased function among older adults with knee OA. Similar studies in healthy older adults found improvements in thigh muscle mass and decreases in thigh fat mass with minimal alteration in total body weight after 16-18 weeks of training. We now propose an 18-month, high-intensity strength-training intervention for older adults with knee OA, focused on improving thigh composition (more muscle and less fat). We hypothesize that in addition to short-term clinical benefits, combining greater duration with high intensity will alter thigh composition sufficiently to attain long-term changes in knee-joint forces, decrease inflammatory cytokines, lower pain levels, and slow OA progression, which has yet to be convincingly demonstrated for any OA treatment. These are important benefits that are not achievable with shorter interventions.

Participants will be randomized to one of 3 groups: high-intensity strength training; low-intensity strength training; or attention control. The primary clinical aim is to compare the interventions' effects on knee pain, and the primary mechanistic aim is to compare their effects on knee-joint compressive forces during walking, a mechanism that affects the OA disease pathway. Secondary aims will compare intervention effects on additional clinical measures of disease severity (e.g., function, mobility); disease progression, measured by xray; thigh muscle and fat volume, measured by CT; components of thigh muscle function, including hip abductor strength and quadriceps strength, power, and proprioception; additional measures of knee-joint loading; and inflammatory and OA biomarkers.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Knee Osteoarthritis

Intervention

• Behavioral: High Intensity Strength Training
  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.
• Behavioral: Low Intensity Strength Training
  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.
• Behavioral: Attention Control
  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.

Study Arms

• Experimental: High Intensity Strength Training
  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.
  Intervention: Behavioral: High Intensity Strength Training
• Experimental: Low Intensity Strength Training
  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.
  Intervention: Behavioral: Low Intensity Strength Training
• Active Comparator: Attention Control
  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.
  Intervention: Behavioral: Attention Control

• Publications *: Messier 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2016): 375
• Original Estimated Enrollment (submitted: December 8, 2011): 372
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Mild to Moderate Knee Osteoarthritis

Exclusion Criteria:

• BMI ≥20 kg/m2 and ≤44.9 kg/m2
• Knee varus malalignment
• Participation in formal strength training for more than 30 min/week in the past 6 months.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01489462
• Other Study ID Numbers: R01AR059105( U.S. NIH Grant/Contract ); 1R01AR059105-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
• Study Sponsor: Wake Forest University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• Principal Investigator: Stephen P Messier, PhD; Wake Forest University

• PRS Account: Wake Forest University Health Sciences
• Verification Date: October 2017