Assessment of Efficacy of Low Intensity Resistance Training in Men at Risk for Symptomatic Knee Osteoarthritis

NCT01487525 | Completed Results

• 1 other identifier: 201109738-MOD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

symptomatic knee osteoarthritis; partial blood flow restriction; knee extensor strength

Outcome Measures

Primary Outcomes (1)

• Change in Isotonic Leg Press 1RM

  double leg press 1 rep maximum strength

  0,6 weeks

Secondary Outcomes (2)

• Isokinetic Knee Extensor Strength

  0, 6 weeks

• Knee Pain

  0, 6 weeks

Study Arms (2)

PBFR-

PLACEBO COMPARATOR

double leg press without application of partial blood flow restriction to the upper leg

Other: Double leg press without partial blood flow restriction

PBFR+

EXPERIMENTAL

double leg press with application of partial blood flow restriction to the upper leg

Device: Double leg press with partial blood flow restriction

Interventions

Double leg press with partial blood flow restriction DEVICE

double isotonic and isokinetic leg press extension with application of partial blood flow restriction to the upper leg

PBFR+

Double leg press without partial blood flow restriction OTHER

double isotonic and isokinetic leg press extension without application of partial blood flow restriction to the upper leg

PBFR-

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Neil Segal
• Organization: University of Iowa

segal-research@uiowa.edu

3193358204

Study Officials

• Neil A Segal, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 7, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-01

Locations

US (1)