Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

NCT05060380 | Withdrawn DMC

• 1 other identifier: 300004541
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.

Conditions

Osteopenia; Osteoporosis; Postmenopausal Osteoporosis; Sarcopenia

Keywords

aging; bone; muscle; exercise

Outcome Measures

Primary Outcomes (3)

• Bone biomarker

  bone formation and resorption marker

  baseline

• Bone biomarker

  bone formation and resorption marker

  1 month

• Bone biomarker

  bone formation and resorption marker

  2 month

Study Arms (2)

Exercise training

EXPERIMENTAL

The exercise training group will receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week for a total of 6 months.

Other: Exercise training

Control

NO INTERVENTION

The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.

Interventions

Exercise training OTHER

Progressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity.

Exercise training

Eligibility Criteria

• Age: 55 Years - 70 Years
• Gender Eligibility Details: Self-identified as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• independent ambulatory
• diagnosed with low bone mass

You may not qualify if:

• uncontrolled hypertension
• secondary osteoporosis
• fragility fracture,
• clinical or laboratory evidence of hepatic
• renal disease,
• uncontrolled disorders of the parathyroid
• thyroid glands,
• a history of cancer in the past 5 years,
• any structured resistance training within the previous year, and
• past therapy with any drug for osteoporosis,
• any current therapy for osteoporosis except zoledronic acid,
• inability to walk independently or
• any other medical conditions which could restrict the potential participants from full participation as decided by their physician.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Sarcopenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• HARSHVARDHAN SINGH, PT, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Model Details: Individuals will be randomly assigned to exercise or no exercise group.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 29, 2021
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)