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Strength Training for ARthritis Trial (START)

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ClinicalTrials.gov Identifier: NCT01489462
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : November 6, 2017
Sponsor:
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  ICMJE November 22, 2011
First Posted Date  ICMJE December 9, 2011
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Strength Training for ARthritis Trial
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2016)
375
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2011)
372
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01489462
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Stephen P Messier, PhD Wake Forest University
PRS Account Wake Forest University Health Sciences
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP