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Behavioural Intervention
Resistance Exercise for Osteoporosis
N/A
Waitlist Available
Led By HARSHVARDHAN SINGH, PT, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with low bone mass
Independent ambulatory
Must not have
History of cancer in the past 5 years
Secondary osteoporosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new muscle-strengthening exercise to see if it is feasible for postmenopausal women with low bone mass.
Who is the study for?
This trial is for postmenopausal women who can walk on their own and have been diagnosed with low bone mass. It's not suitable for those with secondary osteoporosis, uncontrolled high blood pressure, current non-zoledronic acid osteoporosis treatments, liver or kidney disease, unmanaged thyroid issues, recent cancer history, previous year resistance training, inability to walk independently or a fragility fracture.
What is being tested?
The study tests a new muscle-strengthening exercise program over six months to see if it's doable for women with weak bones after menopause. Participants are randomly chosen to either join the exercise group or be in a control group without this specific training.
What are the potential side effects?
Since the intervention involves physical exercise training, potential side effects may include muscle soreness, joint pain or discomfort during and after workouts. However, these are common reactions to starting any new workout regimen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with low bone density.
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I can walk by myself without help.
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I can walk by myself without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer within the last 5 years.
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My bone loss is due to an underlying health condition.
Select...
I have had a fracture from a minor injury.
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I have liver or kidney disease.
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I have taken medication for osteoporosis before.
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I am currently being treated for osteoporosis, but not with zoledronic acid.
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I cannot walk on my own.
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My blood pressure is not controlled by medication.
Select...
My thyroid or parathyroid glands are not functioning properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone biomarker
Secondary study objectives
Muscle strength
Oxygen uptake (VO2)
Physical activity: International Physical Activity Questionnaire (IPAQ)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise trainingExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,672 Total Patients Enrolled
17 Trials studying Osteoporosis
593,420 Patients Enrolled for Osteoporosis
HARSHVARDHAN SINGH, PT, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have done structured resistance training in the past year.I have had cancer within the last 5 years.I have been diagnosed with low bone density.My bone loss is due to an underlying health condition.I have had a fracture from a minor injury.I have liver or kidney disease.I have taken medication for osteoporosis before.I am currently being treated for osteoporosis, but not with zoledronic acid.I cannot walk on my own.I can walk by myself without help.My blood pressure is not controlled by medication.My thyroid or parathyroid glands are not functioning properly.I can walk by myself without help.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise training
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoporosis Patient Testimony for trial: Trial Name: NCT05060380 — N/A
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