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Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis (PBFR2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The American Geriatrics Society
Information provided by (Responsible Party):
Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier:
NCT01440972
First received: September 21, 2011
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators will test the following hypotheses. In comparison with low-intensity resistance training without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:

Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee extensor strength

Secondary Hypotheses:

  1. Increase quadriceps muscle volume assessed by MRI
  2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb
  3. Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Condition Intervention
Knee Osteoarthritis
Symptomatic Knee Osteoarthritis
Other: partial blood flow restriction (PBFR)
Other: low intensity resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Change in isotonic double leg-press 1 repetition maximum strength [ Time Frame: pre-intervention, post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quadriceps muscle volume by magnetic resonance imaging [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in lower limb muscle power by a) double leg-press at 40% 1 repetition maximum and b) timed stair climb [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Knee Injury and Osteoarthritis Outcome Score Pain and Quality of Life subscales [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Change in isokinetic knee extensor strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: September 2011
Estimated Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise without PBFR Other: low intensity resistance training
low intensity resistance training without partial blood flow restriction
Experimental: exercise with PBFR Other: partial blood flow restriction (PBFR)
low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Age 45-65
  • BMI greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis

Exclusion Criteria:

  • Resistance training at any time in the last 3 months prior to study
  • Bilateral knee replacement
  • Lower limb amputation
  • Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
  • Back, hip or knee problems that affect walking ability or ability to exercise
  • Unable to walk without a cane or walker
  • Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
  • Multiple sclerosis
  • Known neuropathy
  • Self-report of Diabetes
  • Currently being treated for cancer or having untreated cancer
  • Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
  • Peripheral Vascular Disease
  • History of myocardial infarction or stroke in the last year
  • History of deep venous thrombosis
  • Chest pain during exercise or at rest
  • Use of supplemental oxygen
  • Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
  • Staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity)
  • Concurrent study participation (such as the MOST study)
  • Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study
  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: NCT01440972

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
The American Geriatrics Society
  More Information

No publications provided

Responsible Party: Neil A Segal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01440972     History of Changes
Other Study ID Numbers: 201109738
Study First Received: September 21, 2011
Last Updated: December 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
knee osteoarthritis
symptomatic knee osteoarthritis
isotonic leg-press strength
isokinetic knee extensor strength
quadriceps volume

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

ClinicalTrials.gov processed this record on November 25, 2014