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Completed

NCT Number: NCT04810975

Strength Training Effects on Musculoskeletal Health

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.

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Key information

Conditions

Musculoskeletal Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle Strength Training

Device

Strength training occurring specific exercise regimens using Exercise Equipment A or B

Primary outcomes

  1. Lean Body Mass

    Time frame: 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.

  2. Body Circumference

    Time frame: 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.

  3. Functional test 1 to assess musculoskeletal strength

    Time frame: 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.

  4. Functional test 2 to assess musculoskeletal strength

    Time frame: 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.

  5. Bone marker activity-bone resorption

    Time frame: 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.

  6. Bone marker activity-bone formation

    Time frame: 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.

  7. Ratio of bone resorption to bone formation

    Time frame: 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.

  8. Hormone levels-Testosterone

    Time frame: 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.

  9. Hormone levels-Cortisol

    Time frame: 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.

  10. Inflammatory Marker

    Time frame: 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.

  11. Rest-activity rhythms

    Time frame: 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.

  12. Melatonin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

  • Jaquish Biomedical

Registry information

Official study title

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

Acronym: Muscle:Time

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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