Hands-Up: Exercise and Education Program After a Wrist Fracture
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|ClinicalTrials.gov Identifier: NCT03997682|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture Osteoporosis||Other: Hands-Up Program||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||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|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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.
Other: Hands-Up Program
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.
- 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
- 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.
- 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
- Grip Strength [ Time Frame: 12 months ]Grip strength measured in kilograms using a grip strength dynamometer: Saehan, Saehan Corp. Masan, Korea.
- Patient Rated Wrist Evaluation [ Time Frame: 12 months ]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.
- Bone Density [ Time Frame: 12 months ]A t-score as measured by the DXA.
- Osteoporosis Knowledge [ Time Frame: 12 months ]An osteoporosis knowledge test, using a scale, out of 30.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997682
|Contact: Joy C MacDermid, PhD||519-646-6100 ext firstname.lastname@example.org|
|Contact: Katrina Munro||519-646-6100 ext email@example.com|
|St. Joseph Health Care|
|London, Ontario, Canada, N6A 4L6|