Strength Training Effects on Musculoskeletal Health

Study Overview
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Brief Summary
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The objective here is to assess the efficacy of variable resistance muscle training on bone, sleep parameters and quality of life in healthy populations of men and women age 30 or older.

Official Title
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Strength Training Effects on Musculoskeletal Health, Melatonin, Rest-activity Rhythms and Quality of Life: Muscle:Time Study

Conditions
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Musculoskeletal Diseases

Intervention / Treatment
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* Device: Muscle Strength Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 years or older (males or females) Baseline strength (e.g., can lift an office chair with no problems) Be willing to participate in a 6-month RCT Be willing to conduct daily muscle training exercises Be willing to maintain a food diary Be willing to consume  2.2g/kg body weight daily Be willing to submit specimens and conduct tests 3 times over 6 months (0, 3 and 6 months) Exclusion Criteria: those who consume vegan or vegetarian diets people with conditions like hypertension and uncontrolled non-medicated blood pressure; cardiovascular disease/heart failure (e.g., arrhythmias, unstable angina, congestive heart failure) COPD drugs that may increase fall risk or make dizzy (e.g., antidepressants, anti-seizure drugs) muscle disease (e.g., myasthenia gravis, myopathy, myositis) active hernia pregnancy muscle atrophy (e.g., Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), ALS) neuro degenerative disease limited mobility those who consume proteins supplements. Individuals who have implanted pacemakers or defibrillators People who suffer from: Marfan syndrome, migraine, hyperparathyroidism, metastatic bone disease, multiple myeloma chronic steroid use individuals with restrictions to movement and exercise

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The effect of exercise A on musculoskeletal health<br> | Device: Muscle Strength Training<br>* Strength training occurring specific exercise regimens using Exercise Equipment A or B<br>|
| Other: The effect of exercise B on musculoskeletal health<br> | Device: Muscle Strength Training<br>* Strength training occurring specific exercise regimens using Exercise Equipment A or B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean Body Mass | Muscle measurements and fat composition will be assessed by Tanita at baseline (month 0) and month 6. Muscle mass, expressed as percentage change from baseline to month 6, will be compared within and between groups at 6 mos. | 0-6 months | 
| Body Circumference | Total body circumference will be measured by Army Body Fat Calculator at baseline (month 0) and month 6. Body circumference, expressed as percentage change from baseline to month 6, will be compared within and between groups at 6 mos. | 0-6 months | 
| Functional test 1 to assess musculoskeletal strength | Functional-Timed Up and Go Test will assess musculoskeletal strength at baseline (month 0) and month 6. Timed up-and-go times, expressed as change from baseline to month 6, will be compared within and between groups at 6 mos. | 0-6 months | 
| Functional test 2 to assess musculoskeletal strength | Functional-Sit-to-Stand Test will assess musculoskeletal strength at baseline (month 0) and month 6. Functional Sit-to-stand times, expressed as change from baseline to month 6, will be compared within and between groups at 6 mos. | 0-6 months | 
| Bone marker activity-bone resorption | Urinary CTx levels will be assessed at baseline (month 0) and month 6. The Effect of muscle strengthening on changes in Human Type 1 Collagen C-telopeptide (CTx) levels from baseline to month 6, will be compared within and between groups at 6 mos. | 0-6 months | 
| Bone marker activity-bone formation | Urinary P1NP levels will be assessed at baseline (month 0) and month 6. The Effect of muscle strengthening on changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels from baseline will be compared within and between groups at 6 mos. | 0-6 months | 
| Ratio of bone resorption to bone formation | Urinary CTx:P1NP levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in the ratio of CTx to P1NP will be assessed at baseline and then compared within and between groups at month 6. | 0-6 months | 
| Hormone levels-Testosterone | Urinary testosterone levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in testosterone levels will be assessed at baseline and then compared within and between groups at month 6. | 0-6 months | 
| Hormone levels-Cortisol | Urinary cortisol levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in cortisol levels will be assessed at baseline and then compared within and between groups at month 6. | 0-6 months | 
| Inflammatory Marker | Urinary C-reactive protein levels will be assessed at baseline (month 0) and then at month 6. The effect of muscle strengthening on changes in CRP will be assessed at baseline and then compared within and between groups at month 6. | 0-6 months | 
| Rest-activity rhythms | Rest activity rhythms will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in rest-activity rhythms will be assessed at baseline and then compared within and between groups at month 6. | 0-6 months | 
| Melatonin | Salivary Melatonin levels will be assessed at baseline (month 0) and month 6. The effect of muscle strengthening on changes in melatonin rhythms will be assessed at baseline and then compared within and between groups at month 6. | 0-6 months |