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Strength Training Effects on Musculoskeletal Health (Muscle:Time)

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ClinicalTrials.gov Identifier: NCT04810975
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
Jaquish Biomedical
Information provided by (Responsible Party):
Duquesne University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Diseases Device: Muscle Strength Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Strength Training Effects on Musculoskeletal Health, Melatonin, Rest-activity Rhythms and Quality of Life: Muscle:Time Study
Actual Study Start Date : December 2, 2021
Estimated Primary Completion Date : June 8, 2026
Estimated Study Completion Date : June 8, 2027
Arms and Interventions
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Arm Intervention/treatment
The effect of exercise A on musculoskeletal health Device: Muscle Strength Training
Strength training occurring specific exercise regimens using Exercise Equipment A or B
The effect of exercise B on musculoskeletal health Device: Muscle Strength Training
Strength training occurring specific exercise regimens using Exercise Equipment A or B


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810975


Contacts
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Contact: Paula Witt-Enderby, Ph.D. 412-396-4296 wittp@duq.edu

Locations
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United States, Pennsylvania
Duquesne University Recruiting
Pittsburgh, Pennsylvania, United States, 15282
Contact: Paula Witt-Enderby, PhD    412-818-7346    wittp@duq.edu   
Sponsors and Collaborators
Duquesne University
Jaquish Biomedical
Investigators
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Principal Investigator: Paula Witt-Enderby, Ph.D. Duquesne University
More Information
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Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT04810975    
Other Study ID Numbers: 2020-12-15
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases