Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Osteoporosis Clinical Trial

Official title:

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05060380
• Other study ID #: 300004541
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2025
• Est. completion date: December 1, 2026

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: HARSHVARDHAN SINGH, PhD
• Phone: 2059961413
• Email: hsingh[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the 6 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in postmenopausal women with low bone mass.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density measured by magnetic resonance imaging (MRI) technique	Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study.	Baseline
Primary	Bone density measured by magnetic resonance imaging (MRI) technique	Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study.	6 months
Secondary	Muscle strength	Change in quadriceps muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study	Baseline
Secondary	Muscle strength	Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study	1 month
Secondary	Muscle strength	Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.	3 months
Secondary	Muscle strength	Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.	6 months
Secondary	Serum bone biomarker: Bone Alkaline Phosphatase (BAP)	Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.	Baseline
Secondary	Serum bone biomarker: Bone Alkaline Phosphatase (BAP)	Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.	1 month
Secondary	Serum bone biomarker: Bone Alkaline Phosphatase (BAP)	Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.	3 months
Secondary	Serum bone biomarker: Bone Alkaline Phosphatase (BAP)	Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.	6 months
Secondary	Physical activity: International Physical Activity Questionnaire (IPAQ)	Change in metabolic equivalent (MET)-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.	baseline
Secondary	Physical activity: International Physical Activity Questionnaire (IPAQ)	Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.	1 month
Secondary	Physical activity: International Physical Activity Questionnaire (IPAQ)	Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.	3 month
Secondary	Physical activity: International Physical Activity Questionnaire (IPAQ)	Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.	6 months
Secondary	Oxygen uptake (VO2)	Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.	Baseline
Secondary	Oxygen uptake (VO2)	Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.	6 months