Strength Training Effects on Musculoskeletal Health

Musculoskeletal Diseases Clinical Trial

— Muscle:Time  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04810975
• Other study ID #: 2020-12-15
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: June 2027

Study information

• Verified date: June 2023
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Duquesne University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	Jaquish Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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