NCT04810975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 18, 2021

Last Update Submit

April 23, 2026

Conditions

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

The effect of exercise A on musculoskeletal health

OTHER
Device: Muscle Strength Training

The effect of exercise B on musculoskeletal health

OTHER
Device: Muscle Strength Training

Interventions

Muscle Strength TrainingDEVICE

Strength training occurring specific exercise regimens using Exercise Equipment A or B

The effect of exercise A on musculoskeletal healthThe effect of exercise B on musculoskeletal health

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Paula Witt-Enderby, Ph.D.

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 23, 2021

Study Start

February 7, 2022

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)