Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05060380

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia Osteoporosis Postmenopausal Osteoporosis Sarcopenia	Other: Exercise training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Postmenopausal women will be randomly assigned to exercise or no exercise group.Postmenopausal women will be randomly assigned to exercise or no exercise group.

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessor will be blinded to the group assignment.

Primary Purpose:

Other

Official Title:

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Bone density measured by magnetic resonance imaging (MRI) technique [Baseline]
Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study.
Bone density measured by magnetic resonance imaging (MRI) technique [6 months]
Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study.

Secondary Outcome Measures

Muscle strength [Baseline]
Change in quadriceps muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study
Muscle strength [1 month]
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study
Muscle strength [3 months]
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.
Muscle strength [6 months]
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.
Serum bone biomarker: Bone Alkaline Phosphatase (BAP) [Baseline]
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Serum bone biomarker: Bone Alkaline Phosphatase (BAP) [1 month]
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Serum bone biomarker: Bone Alkaline Phosphatase (BAP) [3 months]
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Serum bone biomarker: Bone Alkaline Phosphatase (BAP) [6 months]
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Physical activity: International Physical Activity Questionnaire (IPAQ) [baseline]
Change in metabolic equivalent (MET)-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Physical activity: International Physical Activity Questionnaire (IPAQ) [1 month]
Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Physical activity: International Physical Activity Questionnaire (IPAQ) [3 month]
Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Physical activity: International Physical Activity Questionnaire (IPAQ) [6 months]
Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Oxygen uptake (VO2) [Baseline]
Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.
Oxygen uptake (VO2) [6 months]
Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.