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The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. |
|
| Glutamine/Fishoil | Active Comparator | 3.285 g of EPA and 3.285 g of Docosahexaenoic acid (DHA) and L-alanyl-glutamine (8g/d). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine and Fish Oil Supplementation | Drug | This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)). | Baseline |
| 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)). | 90 Days |
| Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Baseline |
| 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Systemic and Local Inflammation | Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL | Baseline |
| 90 Day Systemic and Local Inflammation | Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo C. Colombo, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22082326 | Background | Shahzad K, Chokshi A, Schulze PC. Supplementation of glutamine and omega-3 polyunsaturated fatty acids as a novel therapeutic intervention targeting metabolic dysfunction and exercise intolerance in patients with heart failure. Curr Clin Pharmacol. 2011 Nov;6(4):288-94. doi: 10.2174/157488411798375958. | |
| 26269566 | Derived |
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Seventeen participants were randomized to the active treatment group and 14 to the placebo group. Three participants dropped out in the active treatment group. Two participants dropped out of the placebo group. A total of 14 participants completed the trial in the active treatment group and 12 in the placebo group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
| FG001 | Glutamine/Fishoil | 3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d). Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)). | Posted | Mean | Standard Deviation | Percent | Baseline |
|
90 Days
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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 | Placebo | The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo. Placebo: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian Schulze, MD, PhD | University Hospital Jena | 03641-9 32 41 04 | christian.schulze@med.uni-jena.de |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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|
| Placebo | Drug | This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
|
| Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) |
For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. |
| Baseline |
| 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | 90 Days |
| Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Baseline |
| 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | 90 Days |
| Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Baseline |
| 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | 90 Days |
| Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Baseline |
| 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | 90 Days |
| Percent Change in Peak Effort Oxygen Consumption | Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET). | Baseline to 90 Days |
| 90 Days |
| Wu C, Kato TS, Ji R, Zizola C, Brunjes DL, Deng Y, Akashi H, Armstrong HF, Kennel PJ, Thomas T, Forman DE, Hall J, Chokshi A, Bartels MN, Mancini D, Seres D, Schulze PC. Supplementation of l-Alanyl-l-Glutamine and Fish Oil Improves Body Composition and Quality of Life in Patients With Chronic Heart Failure. Circ Heart Fail. 2015 Nov;8(6):1077-87. doi: 10.1161/CIRCHEARTFAILURE.115.002073. Epub 2015 Aug 12. |
| BG001 | Glutamine/Fishoil | 3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d). Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Glutamine/Fishoil | 3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d). Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. |
|
|
| Primary | 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW) | For isometric contractions, participants contracted against a constant 60-degree angle at the knee (dominant leg) and a constant 30 degree angle at the elbow (dominant arm) for 6 seconds. Participants alternated between flexion and extension, 3 repetitions each with a 30 second rest period between each. Data was collected to determine peak torque to body weight (peak torque (PKTQ)/ body weight (BW)). | Posted | Mean | Standard Deviation | Percent | 90 Days |
|
|
|
| Primary | Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Percent | Baseline |
|
|
|
| Primary | 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Percent | 90 Days |
|
|
|
| Primary | Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Percent | Baseline |
|
|
|
| Primary | 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW)) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Percent | 90 Days |
|
|
|
| Primary | Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Joules | Baseline |
|
|
|
| Primary | 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Joules | 90 Days |
|
|
|
| Primary | Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Watts | Baseline |
|
|
|
| Primary | 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | Watts | 90 Days |
|
|
|
| Primary | Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | msec | Baseline |
|
|
|
| Primary | 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque) | For isokinetic contractions, subjects performed flexion and extension movements at the knee and elbow for 5 repetitions at a speed of 60 degrees/second. This was followed by a rest period of 2.5 minutes. For the second isokinetic protocol, subjects performed 25 repetitions of flexion and extension movements at the knee and elbow at a speed of 180 degrees/second. | Posted | Mean | Standard Deviation | msec | 90 Days |
|
|
|
| Primary | Percent Change in Peak Effort Oxygen Consumption | Peak effort oxygen consumption (VO2 max) is measured using Cardiopulmonary Exercise Testing (CPET). | Posted | Mean | Standard Deviation | Percent | Baseline to 90 Days |
|
|
|
| Secondary | Baseline Systemic and Local Inflammation | Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| Secondary | 90 Day Systemic and Local Inflammation | Systemic and local marker of inflammation as measured by tumor necrosis factor-alpha, units pg/mL | Posted | Mean | Standard Deviation | pg/mL | 90 Days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Glutamine/Fishoil | 3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d). Glutamine and Fish Oil Supplementation: This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days. | 0 | 14 | 0 | 14 | 1 | 14 |
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| D021542 | Amino Acids, Neutral |
| Elbow: Extension |
|
| Elbow: Flexion |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|
| Elbow: Extension, 5 repetitions |
|
| Elbow: Flexion, 5 repetitions |
|
| Knee: Extension, 25 repetitions |
|
| Knee: Flexion, 25 repetitions |
|
| Elbow: Extension, 25 repetitions |
|
| Elbow: Flexion, 25 repetitions |
|