Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Not Applicable

Not yet recruiting

• Conditions: Postmenopausal Osteoporosis; Sarcopenia; Osteoporosis; Osteopenia
• Interventions: Other: Exercise training

• Registration Number: NCT05060380
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training	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.

Primary Outcome Measures

Name	Time	Method
Bone biomarker	2 month	bone formation and resorption marker

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States