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

September 21, 2011
December 1, 2011
September 2011
November 2011   (final data collection date for primary outcome measure)
Change in isotonic double leg-press 1 repetition maximum strength [ Time Frame: pre-intervention, post-intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01440972 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Knee Osteoarthritis
  • Symptomatic Knee Osteoarthritis
  • Other: partial blood flow restriction (PBFR)
    low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
  • Other: low intensity resistance training
    low intensity resistance training without partial blood flow restriction
  • Active Comparator: Exercise without PBFR
    Intervention: Other: low intensity resistance training
  • Experimental: exercise with PBFR
    Intervention: Other: partial blood flow restriction (PBFR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
March 2012
November 2011   (final data collection date for primary outcome measure)

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
Female
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01440972
201109738
No
Neil A Segal, University of Iowa
University of Iowa
The American Geriatrics Society
Not Provided
University of Iowa
December 2011

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