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| Name | Class |
|---|---|
| The American Geriatrics Society | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise without PBFR | Active Comparator |
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| exercise with PBFR | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| partial blood flow restriction (PBFR) | Other | low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass | 4 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Without PBFR | low intensity resistance training: low intensity resistance training without partial blood flow restriction |
| FG001 | Exercise With PBFR | partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| low intensity resistance training | Other | low intensity resistance training without partial blood flow restriction |
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| 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Without PBFR | low intensity resistance training: low intensity resistance training without partial blood flow restriction |
| BG001 | Exercise With PBFR | partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass | Posted | Mean | Standard Deviation | kg per kg body mass | 4 weeks |
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| Secondary | Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging | Posted | Mean | Standard Deviation | Percent change | 4 weeks |
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| Secondary | Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum | Posted | Mean | Standard Deviation | Watts | 4 weeks |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Secondary | Change in Isokinetic Knee Extensor Strength | Posted | Least Squares Mean | Standard Error | Nm/kg | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Without PBFR | low intensity resistance training: low intensity resistance training without partial blood flow restriction | 0 | 24 | 0 | 24 | ||
| EG001 | Exercise With PBFR | partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks. | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neil Segal | University of Iowa | 3193358204 | segal-research@uiowa.edu |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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