Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

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.

Study Overview

• Status: Withdrawn
• Conditions: Sarcopenia; Osteoporosis; Osteopenia; Postmenopausal Osteoporosis
• Intervention / Treatment: Other: Exercise training

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Change in quadriceps muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study	Baseline
Muscle strength	Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study	1 month
Muscle strength	Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.	3 months
Muscle strength	Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.	6 months
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
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
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
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
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
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
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
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
Oxygen uptake (VO2)	Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.	Baseline
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: HARSHVARDHAN SINGH, PT, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: exercise; muscle; aging; bone
• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Metabolic Diseases; Muscular Atrophy; Atrophy; Osteoporosis; Sarcopenia; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
• Other Study ID Numbers: 300004541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No