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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01440972
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : July 30, 2015
Last Update Posted : December 5, 2016
The American Geriatrics Society
Information provided by (Responsible Party):
Neil A Segal, University of Iowa

Brief Summary:

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 or disease Intervention/treatment Phase
Knee Osteoarthritis Symptomatic Knee Osteoarthritis Other: partial blood flow restriction (PBFR) Other: low intensity resistance training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis
Study Start Date : September 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging [ Time Frame: 4 weeks ]
  2. Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum [ Time Frame: 4 weeks ]
  3. Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale [ Time Frame: 4 weeks ]
    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.

  4. Change in Isokinetic Knee Extensor Strength [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01440972

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

Responsible Party: Neil A Segal, Associate Professor, University of Iowa Identifier: NCT01440972     History of Changes
Other Study ID Numbers: 201109738
First Posted: September 27, 2011    Key Record Dates
Results First Posted: July 30, 2015
Last Update Posted: December 5, 2016
Last Verified: October 2016

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

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