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Assessment of Efficacy of Low Intensity Resistance Training in Individuals at Risk for Symptomatic Knee Osteoarthritis (PBFR3)

This study is currently recruiting participants.
Verified December 2011 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
Neil A Segal, University of Iowa
ClinicalTrials.gov Identifier:
NCT01487525
First received: December 1, 2011
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this research study is to determine whether low intensity resistance training with concurrent application of a peripheral blood flow restriction device to the exercising limb will elicit increased quadriceps strength, functional gains, ability to complete knee-related activities of daily living, mobility, and quality of life in individuals at risk for developing symptomatic knee osteoarthritis (OA). It is known that higher quadriceps strength is protective against developing symptomatic knee OA.1 However, people at risk for knee OA frequently do not tolerate the high intensity resistance training that is generally believed necessary to increase muscle strength. Partial blood flow restriction (PBFR) to the exercising muscle has been reported to result in strength gains, while requiring lower levels of joint loading.2 This method may be better tolerated, enabling efficacious exercise in older adults who may not tolerate high knee joint loads.

To asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of PBFR to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in individuals at risk for developing symptomatic knee osteoarthritis,we 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
 Device: double leg press with partial blood flow restriction
Other: double leg press without partial blood flow restriction

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • one rep maximum [ Time Frame: 0,6 weeks ] [ Designated as safety issue: No ]
    double leg press 1 rep maximum strength


Secondary Outcome Measures:
  • lower limb muscle power [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: No ]
    double leg press at 40% of 1 repetition maximum strength

  • lower limb muscle power [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: No ]
    timed stair climb

  • knee pain [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: Yes ]
    knee injury and osteoarthritis outcome score questionnaire pain scale

  • isokinetic knee extensor strength [ Time Frame: 0, 6 weeks ] [ Designated as safety issue: No ]
    isokinetic knee extensor strength


Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PBFR-
strength training exercise without partial blood flow restriction
 Other: double leg press without partial blood flow restriction
double leg press extension without application of partial blood flow restriction to the upper leg
Experimental: PBFR+
strength training exercise with partial blood flow restriction
 Device: double leg press with partial blood flow restriction
double leg press extension with application of partial blood flow restriction to the upper leg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • ≥ 45 years
  • has at least one of the following: BMI≥25, frequent knee symptoms on most of the last 30 days, history of knee injury which rendered individual unable to walk without assistance for at least 2 days, history of knee surgery, diagnosis of 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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487525

Contacts
Contact: Neil Segal, MD, MS 319-335-8196 segal-research@uiowa.edu
Contact: Natalie Glass, MA 319-335-7554 segal-research@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Neil A Segal, MD, MS            
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Neil A Segal, MD, MS University of Iowa
  More Information

No publications provided

Responsible Party: Neil A Segal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01487525     History of Changes
Other Study ID Numbers: 201109738-MOD
Study First Received: December 1, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
symptomatic knee osteoarthritis
partial blood flow restriction
knee extensor strength

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

ClinicalTrials.gov processed this record on May 21, 2013