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Strength Training for ARthritis Trial (START)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Wake Forest School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen P. Messier, Ph.D., Wake Forest University
ClinicalTrials.gov Identifier:
NCT01489462
First received: November 22, 2011
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Behavioral: High Intensity Strength Training
Behavioral: Low Intensity Strength Training
Behavioral: Attention Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strength Training for ARthritis Trial

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Pain [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The investigators will measure short term (6 months) and long term (18 months) changes in compressive forces.


Secondary Outcome Measures:
  • Function [ Time Frame: Baseline, 6 Months, 12 Months, 18 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The investigators will measure short term (6 months) and long term (18 months) changes in inflammatory markers.

  • Thigh Composition [ Time Frame: Baseline, 18 Months ] [ Designated as safety issue: No ]
    The investigators will measure short term (6 months) and long term (18 months) changes in thigh composition.


Estimated Enrollment: 372
Study Start Date: March 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Strength Training 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.
Experimental: Low Intensity Strength Training 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.
Active Comparator: Attention Control 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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to Moderate Knee Osteoarthritis

Exclusion Criteria:

  • BMI ≥25 kg/m2 and ≤40.5 kg/m2
  • Knee varus malalignment
  • Participation in formal strength training for more than 30 min/week in the past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489462

Contacts
Contact: Jovita Newman, MA (336) 758-3969 jollajk@wfu.edu

Locations
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27109
Principal Investigator: Stephen P Messier, PhD         
Sub-Investigator: Paul DeVita, PhD         
Sub-Investigator: Dan Beavers, PhD         
Sub-Investigator: Barbara Nicklas, PhD         
Sub-Investigator: Jeff Williamson, MD,         
Sub-Investigator: Jeff Carr, MD         
Sub-Investigator: Kim Bennell, PhD         
Sub-Investigator: Ali Guermazi, MD         
Sub-Investigator: David Hunter, MD         
Sub-Investigator: Richard Loeser, MD         
Sub-Investigator: Shannon Mihalko, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Stephen P Messier, PhD Wake Forest School of Medicine
  More Information

No publications provided by Wake Forest School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen P. Messier, Ph.D., Principal Investigator, Wake Forest University
ClinicalTrials.gov Identifier: NCT01489462     History of Changes
Other Study ID Numbers: R01AR059105
Study First Received: November 22, 2011
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Arthritis
Osteoarthritis
Strength Training

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014