Knee Osteoarthritis, Symptomatic Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, symptomatic knee osteoarthritis, isotonic leg-press strength, isokinetic knee extensor strength, quadriceps volume
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
Interventions
OTHERpartial blood flow restriction (PBFR)
low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
low intensity resistance training without partial blood flow restriction
Sponsors
The American Geriatrics Society
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Change in Isokinetic Knee Extensor Strength | 4 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Without PBFR low intensity resistance training: low intensity resistance training without partial blood flow restriction | 21 |
| Exercise With PBFR partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks. | 19 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Exercise Without PBFR | Exercise With PBFR | Total |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 6.9 | 56.1 years STANDARD_DEVIATION 5.9 | 55.4 years STANDARD_DEVIATION 6.5 |
| Gender Female | 21 Participants | 19 Participants | 40 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Without PBFR | Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass | 0.2 kg per kg body mass | Standard Deviation 0.3 |
| Exercise With PBFR | Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass | 0.4 kg per kg body mass | Standard Deviation 0.3 |
Secondary
Change in Isokinetic Knee Extensor Strength
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exercise Without PBFR | Change in Isokinetic Knee Extensor Strength | -0.05 Nm/kg | Standard Error 0.03 |
| Exercise With PBFR | Change in Isokinetic Knee Extensor Strength | .07 Nm/kg | Standard Error 0.03 |
Secondary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Without PBFR | Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale | 1.8 units on a scale | Standard Deviation 2.7 |
| Exercise With PBFR | Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale | 2.0 units on a scale | Standard Deviation 2.8 |
Secondary
Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Without PBFR | Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum | 0.42 Watts | Standard Deviation 0.26 |
| Exercise With PBFR | Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum | .62 Watts | Standard Deviation 0.27 |
Secondary
Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Without PBFR | Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging | 0.01 Percent change | Standard Deviation 0.73 |
| Exercise With PBFR | Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging | 1.3 Percent change | Standard Deviation 0.8 |