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

NCT01440972 | Completed Results

• 1 other identifier: 201109738
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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; Symptomatic Knee Osteoarthritis

Keywords

knee osteoarthritis; symptomatic knee osteoarthritis; isotonic leg-press strength; isokinetic knee extensor strength; quadriceps volume

Outcome Measures

Primary Outcomes (1)

• Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass

  4 weeks

Secondary Outcomes (4)

• Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging

  4 weeks

• Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum

  4 weeks

• Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale

  4 weeks

• Change in Isokinetic Knee Extensor Strength

  4 weeks

Study Arms (2)

Exercise without PBFR

ACTIVE COMPARATOR

Other: low intensity resistance training

exercise with PBFR

EXPERIMENTAL

Other: partial blood flow restriction (PBFR)

Interventions

partial blood flow restriction (PBFR) OTHER

low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.

exercise with PBFR

low intensity resistance training OTHER

low intensity resistance training without partial blood flow restriction

Exercise without PBFR

Eligibility Criteria

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

You may qualify if:

• 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

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
• The American Geriatrics Society: collaborator

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

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 27, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 5, 2016
• Results First Posted: July 30, 2015

Record last verified: 2016-10

Locations

US (1)