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Behavioural Intervention
Strength Training Intensity for Osteoporosis
N/A
Recruiting
Led By Lora Giangregorio, PhD
Research Sponsored by University of Waterloo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported as postmenopausal for ≥ 2 years, OR postmenopausal stats confirmed via blood test (female participants only)
Age 50 or over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 12 months
Awards & highlights
Study Summary
This trial will look at different types of exercise to see what is most effective for people with osteoporosis in order to prevent fractures, disability, and premature death.
Who is the study for?
This trial is for individuals over 50 with low bone density or high fracture risk who have declined osteoporosis medication. Participants must be postmenopausal, willing to exercise twice weekly, and fully vaccinated against COVID-19. Those already doing similar training or with conditions affecting bone health cannot join.Check my eligibility
What is being tested?
The study tests the effects of different exercise intensities on bone strength in people at risk for fractures due to low bone mineral density. It compares supervised strength training at two intensity levels versus home exercises.See study design
What are the potential side effects?
While specific side effects are not listed, resistance training can sometimes lead to muscle soreness, joint pain, or injury if not done correctly. The trial aims to find safe exercise intensities for those with fragile bones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who has been postmenopausal for 2 years or more, or this has been confirmed by a blood test.
Select...
I am 50 years old or older.
Select...
I have received 2 COVID-19 vaccinations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone structure of lumbar vertebra
Secondary outcome measures
10 Metre Walk Test.
30 Second Chair Stand Test.
6 Minute Walk Test.
+27 moreOther outcome measures
Dietary Intake
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Supervised strength training (group 2)Experimental Treatment1 Intervention
In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.
Group II: Supervised strength training (group 1)Experimental Treatment1 Intervention
In-person, supervised muscle strengthening exercises twice weekly at a specific intensity.
Group III: Home exerciseActive Control1 Intervention
Home exercise program, with biweekly group virtual education and exercise classes.
Find a Location
Who is running the clinical trial?
University of WaterlooLead Sponsor
124 Previous Clinical Trials
209,034 Total Patients Enrolled
University of SaskatchewanOTHER
251 Previous Clinical Trials
154,086 Total Patients Enrolled
University Health Network, TorontoOTHER
1,473 Previous Clinical Trials
484,681 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects my bone health.I cannot communicate in English.I am a woman who has been postmenopausal for 2 years or more, or this has been confirmed by a blood test.I have had cancer other than non-melanoma skin cancer in the last 2 years.I am at high risk for bone fractures and have chosen not to take or stopped taking osteoporosis medication.You have been diagnosed with dementia.Your bone density score is low, or you have a high risk of breaking a bone based on a fracture probability test.I have major surgery planned within a year.You are planning to travel for more than 6 weeks.I have been on medication for my bones for the last year or more.You have reasons that make it unsafe for you to do resistance training.You are already doing intense muscle-strengthening exercises at least twice a week.I am 50 years old or older.I am receiving care focused on relieving symptoms.I have received 2 COVID-19 vaccinations.I have had a spine fracture in the past year or a limb fracture in the past 6 months.You weigh more than 450 pounds.I had a joint replacement within the last 6 months.Your bone density test shows that you have a high risk of getting a bone fracture.
Research Study Groups:
This trial has the following groups:- Group 1: Supervised strength training (group 2)
- Group 2: Home exercise
- Group 3: Supervised strength training (group 1)
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.
Osteopenia Patient Testimony for trial: Trial Name: NCT05541432 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for individuals to join this medical research?
"Clinicaltrials.gov indicates that this trial is currently recruiting individuals for participation, with the initial posting on September 13th 2022 and an edit made to it as recently as November 1st 2022."
Answered by AI
How many individuals have enrolled in this trial so far?
"Affirmative. As seen on clinicaltrials.gov, which was last modified in November 1st 2022, this research is actively searching for volunteers and has recruited 324 participants across a single medical facility so far. The study was originally posted on September 13th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Quebec
Arizona
Iowa
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
1
2
Why did patients apply to this trial?
The more information we have, the better able we will be in the future to have many treatment options.
PatientReceived 1 prior treatment
Tried Boniva but stopped after unacceptable side effects. No other drug treatment options appear to be any better as far as side effects.
PatientReceived 1 prior treatment
I was menopause at 38 years old. Diagnosed with Osteoporosis at 42, and was on Fosomax for about 8 years. Stopped taking that because my condition worsened. Began with a Naturopath, and had been on Strontium and Bone Basics for several years. Just stopped taking those pills recently.
PatientReceived no prior treatments
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