Musculoskeletal Diseases
Conditions
Brief summary
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.
Interventions
DEVICEMuscle Strength Training
Strength training occurring specific exercise regimens using Exercise Equipment A or B
Sponsors
Jaquish Biomedical
Duquesne University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Marker | 0-6 months | 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. |
| Rest-activity rhythms | 0-6 months | 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. |
| Lean Body Mass | 0-6 months | 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. |
| Body Circumference | 0-6 months | 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. |
| Functional test 1 to assess musculoskeletal strength | 0-6 months | 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. |
| Functional test 2 to assess musculoskeletal strength | 0-6 months | 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. |
| Bone marker activity-bone resorption | 0-6 months | 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. |
| Bone marker activity-bone formation | 0-6 months | 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. |
| Ratio of bone resorption to bone formation | 0-6 months | 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. |
| Hormone levels-Testosterone | 0-6 months | 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. |
| Hormone levels-Cortisol | 0-6 months | 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. |
| Melatonin | 0-6 months | 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. |
Countries
United States
Outcome results
None listed