- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997682
Hands-Up: Exercise and Education Program After a Wrist Fracture
Hands-Up Program: Protocol for a Feasibility Study of a Combined Exercise and Education Randomized Controlled Trial of a 6-week Intervention in People With a Distal Radius Fracture
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants included in this study will be recruited from the Hand and Upper Limb Clinic (HULC) at St. Joseph's Hospital. Patients at HULC are routinely tested function and strength and use questionnaires that ask about pain and disability. These procedure help to monitor usual recovery. Participation in this study will require being screened for eligibility and informed about the study by their surgeon or their delegate,who is a research assistant working on this project. By using a computer-generated sequence, the participant will be randomly allocated to either of the following treatment groups:
- Usual physical therapy OR
- Usual physical therapy AND Hands-Up Program (Exercise and Education) The standard care for a distal radius fracture would include receiving an assessment related to whether casting or surgery is necessary. The participant may be in a cast for 6 weeks with routine check up and x-rays to monitor the healing, at 3 months, 6 months and 12 months. The participant should receive some physical therapy related to restoring function of the hand and wrist.
In addition to the usual care, being allocated to the intervention group would require the participant to attend an exercise and education program once their cast has been removed and they've restored some strength and function in their hand and wrist. The exercise portion of the intervention will focus on strength and balance training, with aspects of managing distal radius fracture healing as well. The education will focus on learning about risk factors for a distal radius fracture, osteoporosis, exercise for adults, nutrition for adults and falls prevention strategies. Both the exercise and education programs will take place at the HULC clinical research lab. The participant will be asked to come in two times per week for approximately 75 minutes per session. The participant will have 45 minutes of exercise which will include upper and lower body strength training, balance and some hand and wrist rehabilitation, followed by 30 minutes of education related to distal radius fractures, osteoporosis education, exercise, nutrition and falls prevention.
The control group will receive the educational materials (one-page info graphics) at the end of the 12-month study participation.
On the participant's initial visit, they will be asked to fill out questionnaires to assess their symptoms related with pain, disability and function. The investigators will conduct several strength assessments such as, a pinch strength test, grip strength, lower body strength and upper body strength. The investigators will take a bone mineral density assessment using a dual energy x-ray absorptiometry (DXA), of the spine, hip and wrist. Follow-up visits for the study will be similar to our usual follow-up, which takes place at 6 week, 3 month, 6 months and 12 months after the participant's initial visit. Specifically, at baseline the participant will be asked to have a DXA (an X-ray measuring your bone density), complete some questionnaires and perform strength and balance assessments. The DXA assessment will not be done at the 6 week, 3 month assessment, but the questionnaires and strength and balance assessments wee be done at those time points. At the 12 month mark all of the outcome assessments will be repeated, including the DXA. Additionally, a physical activity diary will be provided at the initial visit which will be maintained as a daily log of exercise and physical activity during the study period (for one-year). The participant will be asked to bring the physical activity diary to the follow-up visits (at 6 weeks, 3 months, 6 months, and 12 months) so that research staff can keep a copy of physical activity log completed during the study period.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joy C MacDermid, PhD
- Phone Number: 64636 519-646-6100
- Email: jmacderm@uwo.ca
Study Contact Backup
- Name: Katrina Munro
- Phone Number: 64640 519-646-6100
- Email: katrina.munro@sjhc.london.on.ca
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A 4L6
- St. Joseph Health Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient attending the Roth | McFarlane Hand and Upper Limb Clinic (HULC)
- Patients that have had a low-impact distal radius fracture (DRF) within the last 6-10 weeks
- Aged 50-65
- Able to speak and understand English
- Are able to provide informed consent
Exclusion Criteria:
- Any contraindications to exercise
- Progressive neurological disorders that would affect study participation
- Unable to stand or walk independently
- Unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hands-Up Program
Participants will be guided through a 45 minutes exercise program, set up as a group exercise class, with program modifications being made for each individual participant.
In order to meet the requisite number of participants there will be approximately 4 cohorts of 10 participants.
Immediately after the exercise class participants will attend a 30-minute educational session.
The educational sessions will cover bone health principles, nutrition for bone health, osteoporosis practice guidelines, ways to self-monitor balance and lower extremity strength, impacts of physical activity, home hazard detection, hazards at work and in the community, postural effects on bone loading and fracture risk, and integrating physical activity in daily life.
Nutritional education will emphasize the importance of calcium and vitamin D, sources of both diary and dairy free calcium, vitamin D supplements, the importance of protein, and meat and meat-free sources of protein.
|
In addition to the usual care, being allocated to the intervention group would require the participant to attend an exercise and education program once their cast has been removed and they've restored some strength and function in their hand and wrist.
The exercise portion of the intervention will focus on strength and balance training, with aspects of managing our distal radius fracture healing as well.
The education will focus on learning about risk factors for a distal radius fracture, osteoporosis, exercise for adults, nutrition for adults and falls prevention strategies.
|
No Intervention: Standard Care
The control group will receive usual care after a distal radius fracture.
The standard care for a distal radius fracture will receive an assessment related to whether casting or surgery is necessary.
The participant may be in a cast for 6 weeks with routine check up and x-rays to monitor the healing, at 3 months, 6 months and 12 months.
The participant should receive some physical therapy related to restoring function of the hand and wrist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment
Time Frame: 12 months
|
Number of participants recruited in one year.
Recruitment will be feasible if 74 participants are recruited within 12 months
|
12 months
|
Feasibility of Retention
Time Frame: 12 months
|
number of participants that attend the final study visit.
Feasibility will be met if 75% of participants attend the final study visit.
|
12 months
|
Feasibility of Adherence
Time Frame: 12 months
|
Number of participants attending each exercise class.
Feasibility will be met if the participant attends greater than 60% of the exercise classes
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip Strength
Time Frame: 12 months
|
Grip strength measured in kilograms using a grip strength dynamometer: Saehan, Saehan Corp. Masan, Korea.
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12 months
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Patient Rated Wrist Evaluation
Time Frame: 12 months
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Self-reported pain and function from the patient rated wrist evaluation.
The overall score will be assessed at each time point.
The overall score is out of 100.
Units on a scale.
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12 months
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Bone Density
Time Frame: 12 months
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A t-score as measured by the DXA.
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12 months
|
Osteoporosis Knowledge
Time Frame: 12 months
|
An osteoporosis knowledge test, using a scale, out of 30.
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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