search
Back to results

Strength Training Effects on Musculoskeletal Health (Muscle:Time)

Primary Purpose

Musculoskeletal Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Muscle Strength Training
Sponsored by
Duquesne University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Diseases

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duquesne University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

The effect of exercise A on musculoskeletal health

The effect of exercise B on musculoskeletal health

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2021
Last Updated
June 22, 2023
Sponsor
Duquesne University
Collaborators
Jaquish Biomedical
search

1. Study Identification

Unique Protocol Identification Number
NCT04810975
Brief Title
Strength Training Effects on Musculoskeletal Health
Acronym
Muscle:Time
Official Title
Strength Training Effects on Musculoskeletal Health, Melatonin, Rest-activity Rhythms and Quality of Life: Muscle:Time Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duquesne University
Collaborators
Jaquish Biomedical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The effect of exercise A on musculoskeletal health
Arm Type
Other
Arm Title
The effect of exercise B on musculoskeletal health
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Muscle Strength Training
Intervention Description
Strength training occurring specific exercise regimens using Exercise Equipment A or B
Primary Outcome Measure Information:
Title
Lean Body Mass
Description
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.
Time Frame
0-6 months
Title
Body Circumference
Description
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.
Time Frame
0-6 months
Title
Functional test 1 to assess musculoskeletal strength
Description
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.
Time Frame
0-6 months
Title
Functional test 2 to assess musculoskeletal strength
Description
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.
Time Frame
0-6 months
Title
Bone marker activity-bone resorption
Description
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.
Time Frame
0-6 months
Title
Bone marker activity-bone formation
Description
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.
Time Frame
0-6 months
Title
Ratio of bone resorption to bone formation
Description
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.
Time Frame
0-6 months
Title
Hormone levels-Testosterone
Description
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.
Time Frame
0-6 months
Title
Hormone levels-Cortisol
Description
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.
Time Frame
0-6 months
Title
Inflammatory Marker
Description
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.
Time Frame
0-6 months
Title
Rest-activity rhythms
Description
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.
Time Frame
0-6 months
Title
Melatonin
Description
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.
Time Frame
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Witt-Enderby, Ph.D.
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duquesne University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Strength Training Effects on Musculoskeletal Health

We'll reach out to this number within 24 hrs