Muscle:Time: Strength Training Effects on Musculoskeletal Health

Sponsor
Duquesne University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04810975
Collaborator
Jaquish Biomedical (Industry)
40
1
2
66.2
0.6

Study Details

Study Description

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
  • Device: Muscle Strength Training
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 2, 2021
Anticipated Primary Completion Date :
Jun 8, 2026
Anticipated Study Completion Date :
Jun 8, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: The effect of exercise A on musculoskeletal health

Device: Muscle Strength Training
Strength training occurring specific exercise regimens using Exercise Equipment A or B

Other: 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

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duquesne University Pittsburgh Pennsylvania United States 15282

Sponsors and Collaborators

  • Duquesne University
  • Jaquish Biomedical

Investigators

  • Principal Investigator: Paula Witt-Enderby, Ph.D., Duquesne University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duquesne University
ClinicalTrials.gov Identifier:
NCT04810975
Other Study ID Numbers:
  • 2020-12-15
First Posted:
Mar 23, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022