Strength Training Effects on Musculoskeletal Health (Muscle:Time)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Device: Muscle Strength Training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15282
      • Duquesne University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duquesne University
• Collaborators: Jaquish Biomedical
• Investigators: Principal Investigator: Paula Witt-Enderby, Ph.D., Duquesne University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 2020-12-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No