Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Primary Purpose
Osteopenia, Osteoporosis, Postmenopausal Osteoporosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional other trial for Osteopenia focused on measuring aging, bone, muscle, exercise
Eligibility Criteria
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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise training
Control
Arm Description
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.
The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Muscle strength
Change in quadriceps muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study
Muscle strength
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study
Muscle strength
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.
Muscle strength
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.
Oxygen uptake (VO2)
Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.
Full Information
NCT ID
NCT05060380
First Posted
July 28, 2021
Last Updated
September 7, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05060380
Brief Title
Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Official Title
Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Osteoporosis, Postmenopausal Osteoporosis, Sarcopenia
Keywords
aging, bone, muscle, exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Postmenopausal women will be randomly assigned to exercise or no exercise group.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be blinded to the group assignment.
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Progressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity.
Primary Outcome Measure Information:
Title
Bone density measured by magnetic resonance imaging (MRI) technique
Description
Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study.
Time Frame
Baseline
Title
Bone density measured by magnetic resonance imaging (MRI) technique
Description
Change in trabecular density assessed using MRI technique. An increase in trabecular density is expected at the end of the study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Change in quadriceps muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study
Time Frame
Baseline
Title
Muscle strength
Description
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study
Time Frame
1 month
Title
Muscle strength
Description
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.
Time Frame
3 months
Title
Muscle strength
Description
Change in muscle strength assessed using isokinetic dynamometer. An increased quadriceps strength is expected at the end of the study.
Time Frame
6 months
Title
Serum bone biomarker: Bone Alkaline Phosphatase (BAP)
Description
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Time Frame
Baseline
Title
Serum bone biomarker: Bone Alkaline Phosphatase (BAP)
Description
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Time Frame
1 month
Title
Serum bone biomarker: Bone Alkaline Phosphatase (BAP)
Description
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Time Frame
3 months
Title
Serum bone biomarker: Bone Alkaline Phosphatase (BAP)
Description
Change in BAP assessed using assay techniques. An increase in BAP is expected at the end of the study.
Time Frame
6 months
Title
Physical activity: International Physical Activity Questionnaire (IPAQ)
Description
Change in metabolic equivalent (MET)-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Time Frame
baseline
Title
Physical activity: International Physical Activity Questionnaire (IPAQ)
Description
Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Time Frame
1 month
Title
Physical activity: International Physical Activity Questionnaire (IPAQ)
Description
Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Time Frame
3 month
Title
Physical activity: International Physical Activity Questionnaire (IPAQ)
Description
Change in MET-minute scores assessed using IPAQ questionnaire. An improved MET-minute score is expected at the end of this study.
Time Frame
6 months
Title
Oxygen uptake (VO2)
Description
Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.
Time Frame
Baseline
Title
Oxygen uptake (VO2)
Description
Change in VO2 assessed using metabolic cart. A greater value of VO2 is expected at the end of this study.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-identified as female.
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HARSHVARDHAN SINGH, PhD
Phone
2059961413
Email
hsingh@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Donald Lein, PT, PhD
Phone
205-934-0241
Email
dlein@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HARSHVARDHAN SINGH, PT, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HARSHVARDHAN SINGH
Phone
205-996-1413
Email
hsingh@uab.edu
First Name & Middle Initial & Last Name & Degree
HARSHVARDHAN SINGH, PT,PHD
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
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