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lack of funding to pay for a coordinator and interventionist,
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Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy plus Protein Supplement | Experimental | Participants will be randomized to the protein supplementation group, PROT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app. |
|
| Physical Therapy Control | Active Comparator | Participants will be randomized to the enhanced-care control group, CONT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein (PROT) | Dietary Supplement | Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of individuals that complied with treatment/intervention | Compliance among treatment group in meeting 2 g/kg protein goal as measured by protein tracking app and in protein supplements provided will be measured. | up to 6 months |
| Percentage of frequency individuals successfully used the protein tracking app | Compliance in usage of protein tracking app will be recorded. The number of days they logged in and recorded their intake vs. total potential days to provide % value of diet protein compliance. | up to 6 months |
| Percentage of physical therapy visits attended by individuals | Compliance in physical therapy will be recorded. | up to 6 months |
| Percentage counseling sessions attended by individuals | Compliance in attending nutritional counseling sessions will be recorded. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Single Leg Hop Test | Functional healing time based on single leg hop test. The distance the participant hopped on one leg will be recorded and measured in centimeters. This will be done three times and an average will be given. | baseline and up to 6 month |
| Six Meter Timed Hop Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Miller, Ph.D. | Wake Forest University Health Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24088967 | Background | Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705. | |
| 21539650 | Background | Ohura T, Nakajo T, Okada S, Omura K, Adachi K. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial). Wound Repair Regen. 2011 May-Jun;19(3):330-6. doi: 10.1111/j.1524-475X.2011.00691.x. |
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The IPD will be available for health history, surgery type, clinical outcomes, and length of time in study.
The data will be available once the study is completed for a 12-month period.
Interested parties should contact the PI- Gary Miller - for access
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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Physical therapy staff will be blinded.
|
| Control (CONT) | Other | Instructed not to alter their diet based on the app, and to continue to eat as they normally would. |
|
Functional healing time based six meter timed hop test. The time it took the participant to hop six meters on foot will be measured and recorded. |
| baseline and up to 6 month |
| Change in strength in leg flexion and extension | Strength in leg flexion and extension, as measured by Biodex machine | baseline and up to 6 month |
| Change in muscle hypertrophy | depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference. | baseline and up to 6 month |
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