Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

NCT ID: NCT05060380

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-01

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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In 2008, medical cost of osteoporosis and osteoporosis-related fractures was estimated to be $22 billion. This is further expected to rise because of an increase of 20% in population with osteoporosis, amounting to 12 million adults over the age of 50 years, by 2020, out of which 80% will be postmenopausal women. Unfortunately, benefits due to pharmacological interventions have plateaued. Consequently, there is a critical need to identify complementary therapies to enhance the treatment of low bone mass in older adults. The aim of this study is to examine the feasibility of novel progressive muscle resistance exercise in postmenopausal women with low bone mass. Muscle will be assessed via imaging techniques and isokinetic dynamometer. Physical activity will be assessed via activity monitors. Blood will be collected to assess bone and muscle biomarkers. Balance will be assessed via clinical and biomechanical tests. Testing will be performed at 4 time points: baseline, 1 month, 3 month, and 6 months except imaging which will be done at the baseline and 6 months. The findings from this study will help us to understand the feasibility of resistive muscle exercise program in postmenopausal women with low bone mass.

Conditions

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Osteopenia Osteoporosis Postmenopausal Osteoporosis Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individuals will be randomly assigned to exercise or no exercise group.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor will be blinded to the group assignment.

Study Groups

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Exercise training

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.

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* independent ambulatory
* diagnosed with low bone mass

Exclusion Criteria

* 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Harshvardhan Singh

PRINCIPAL INVESTIGATOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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HARSHVARDHAN SINGH, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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300004541

Identifier Type: -

Identifier Source: org_study_id

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