Strength Training Effects on Musculoskeletal Health

Not Applicable

Active, not recruiting

• Conditions: Musculoskeletal Diseases
• Interventions: Device: Muscle Strength Training

• Registration Number: NCT04810975
• Lead Sponsor: Duquesne University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-12-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The effect of exercise A on musculoskeletal health	Muscle Strength Training	-
The effect of exercise B on musculoskeletal health	Muscle Strength Training	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Duquesne University; 🇺🇸 Pittsburgh, Pennsylvania, United States