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Telehealth Intervention for Osteoporosis in Older Men (MisterFIt Trial)
N/A
Recruiting
Led By Suzanne Morin, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fracture at any skeletal site (excluding skull, hands, and feet) within the previous 2 years
Community-dwelling individuals ≥ 60 years who self-identify as men with high risk for fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Awards & highlights
MisterFIt Trial Summary
This trial aims to reduce the burden of osteoporosis in men by addressing the barriers to their engagement in health behaviour change to prevent fractures.
Who is the study for?
This trial is for community-dwelling men over 60 with a high risk of fractures, who have had previous fragility fractures or are on certain anti-osteoporosis medications. They must be able to communicate in English or French and have access to technology for telehealth. Men already doing similar exercises twice a week, unable to perform daily activities, or with severe cognitive issues cannot join.Check my eligibility
What is being tested?
The study tests a virtual fracture prevention program tailored for older men at high risk of fractures against an attention control group. It includes gender-specific strength training, balance exercises, and nutritional counseling delivered online alongside standard anti-osteoporosis drugs.See study design
What are the potential side effects?
Since the intervention primarily involves exercise and nutrition advice delivered virtually, side effects may include typical exercise-related risks such as muscle soreness or strain. The specific side effects will depend on individual health conditions.
MisterFIt Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a bone break, not including skull, hands, or feet, in the last 2 years.
Select...
I am a man over 60 at high risk for breaking bones and live in my own home.
Select...
I have had a hip or spine fracture or multiple weak-bone fractures after age 40.
Select...
I am taking medication approved by Health Canada to lower my risk of bone fractures.
MisterFIt Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 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
Adherence to the exercise and nutrition interventions (feasibility objective)
Perceived usability and satisfaction of the telehealth platform application (feasibility objective)
Study recruitment rates (feasibility objective)
+1 moreSecondary outcome measures
Change in balance
Change in dynamic balance
Change in fear of falling in community-dwelling older adults
+14 moreMisterFIt Trial Design
2Treatment groups
Experimental Treatment
Group I: Misterfit online groupExperimental Treatment1 Intervention
The Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education.
Group II: MisterFit offline groupExperimental Treatment1 Intervention
The Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attention Control
2014
Completed Phase 2
~6520
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
447 Previous Clinical Trials
159,692 Total Patients Enrolled
3 Trials studying Osteoporosis
146 Patients Enrolled for Osteoporosis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,507 Total Patients Enrolled
18 Trials studying Osteoporosis
5,359 Patients Enrolled for Osteoporosis
Suzanne Morin, MDPrincipal InvestigatorResearch Institute of the McGill University Health Centre
1 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spine fracture in the last 4 months or a limb fracture in the last 2 months.I have had a bone break, not including skull, hands, or feet, in the last 2 years.I haven't had worsening heart failure or COPD issues recently.I have low bone density and either a severe spine fracture, certain health conditions, or have fallen twice last year.Currently participating in a similar exercise program at least twice a week.I am a man over 60 at high risk for breaking bones and live in my own home.I cannot communicate in English or French.You are unable to do everyday tasks by yourself or have severe memory problems or a very serious illness.Your risk of a serious bone fracture in the next ten years is very high, at least 20%, according to the FRAX tool.I have been advised against exercise but have doctor's approval to participate.I have had a hip or spine fracture or multiple weak-bone fractures after age 40.I am taking medication approved by Health Canada to lower my risk of bone fractures.
Research Study Groups:
This trial has the following groups:- Group 1: Misterfit online group
- Group 2: MisterFit offline group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At what venues is this research being conducted?
"Presently, 5 sites across Canada are enrolling patients for this trial. Locations include Hamilton, Toronto and Montreal as well as other cities throughout the country. To reduce travel time it is beneficial to select a clinic nearest you if you decide to participate in the study."
Answered by AI
What are the specific goals of this research endeavor?
"The primary evaluation of this trial, conducted over the course of 12 months, will focus on retention rates. Other objectives to be assessed include changes in health-related quality of life (as measured by EuroQol five-dimension questionnaire), action planning phase behavior (using Health Action Process Approach Questionnaire) and confidence for physical activity/calcium intake related behaviors (Osteoporosis Self-Efficacy Scale)."
Answered by AI
How many volunteers are actively participating in this research endeavor?
"This study necessitates 60 qualified participants. Those interested may enroll in this trial at McMaster University in Hamilton, Ontario or the University Health Network in Toronto, Quebec."
Answered by AI
Are there any vacancies available for those wishing to join this clinical trial?
"Affirmative. In accordance with information found on clinicaltrials.gov, this research is actively seeking suitable participants to join the trial which was initially posted on February 7th 2023 and revised June 28th 2023. 60 individuals must be recruited from 5 sites across the country."
Answered by AI
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