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

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Symptomatic Knee Osteoarthritis
• Intervention / Treatment: Other: low intensity resistance training; Other: partial blood flow restriction (PBFR)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 weeks
Change in Isokinetic Knee Extensor Strength		4 weeks

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: The American Geriatrics Society

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 23, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: knee osteoarthritis; isokinetic knee extensor strength; quadriceps volume; symptomatic knee osteoarthritis; isotonic leg-press strength
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 201109738