Distal Radius FractureNCT03997682
Hands-Up: Exercise and Education Program After a Wrist Fracture
A study testing Hands-Up Program in people with Distal Radius Fracture and Osteoporosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Osteoporosis is a bone disease that increases the risk of fractures. People aged 50-65 diagnosed with osteoporosis feel too young to have the disease. But this happens. They need to learn how to modify their lifestyle to minimize the chances of fractures. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Distal Radius Fracture, Osteoporosis
- What is being tested?
- Hands-Up Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 10 Mar 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any contraindications to exercise
- Progressive neurological disorders that would affect study participation
- Unable to stand or walk independently
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
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
Osteoporosis is a bone disease that increases the risk of fractures. People aged 50-65 diagnosed with osteoporosis feel too young to have the disease. But this happens. They need to learn how to modify their lifestyle to minimize the chances of fractures. In this age group, a wrist fracture is usually the first sign of osteoporosis. Fracture risk increases if they are not taught to exercise, eat properly, and identifies fall risk factors early in their diagnosis. Some studies have looked at interventions for osteoporosis in women over the age of 65, but by this age they have likely already had a spine fracture. No studies have addressed the early-onset osteoporosis age group, intervening before spine fractures occur. I will develop an exercise, nutrition, and falls prevention education program to improve the strength, balance and knowledge of people aged 50-65 who had an osteoporotic wrist fracture. I will use this treatment approach and determine if it is more effective than the usual way of treating people with wrist fractures, determining if this is a better strategy for managing osteoporosis. I will have two groups of patients. First, those, over six weeks, receive twice weekly classes that include exercise and education. Here the focus is on bone health and fracture prevention. The control will receive usual physical therapy and the educational materials at the end of their study participation. The treatment will be randomly allocated to 74 men and women between the ages of 50-65 years of age who are 6-10 weeks post-fracture. The outcomes on both groups will be assessed and compared. I will focus on hand function, balance, fall hazard detection, and a bone health behaviour checklist. Using these outcomes, I can determine which treatment approach works best. Osteoporosis affects one in three women and one in five men, making this an important study to improve the lives for many Canadians. The risk of osteoporosis fractures increases with age, making early interventions critical.
Read the 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.
- Conditions
- Distal Radius Fracture, Osteoporosis
- Being tested
- Hands-Up Program
- Medical subject headings
- Wrist Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-Up ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hands-Up Program | Experimental | 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. Receives: Other: Hands-Up Program |
| Standard Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Number of participants recruited in one year. Recruitment will be feasible if 74 participants are recruited within 12 months
Measured: 12 months
Feasibility of Retention
number of participants that attend the final study visit. Feasibility will be met if 75% of participants attend the final study visit.
Measured: 12 months
Feasibility of Adherence
Number of participants attending each exercise class. Feasibility will be met if the participant attends greater than 60% of the exercise classes
Measured: 12 months
Secondary outcomes (4)
Grip Strength
Grip strength measured in kilograms using a grip strength dynamometer: Saehan, Saehan Corp. Masan, Korea.
Measured: 12 months
Patient Rated Wrist Evaluation
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.
Measured: 12 months
Bone Density
A t-score as measured by the DXA.
Measured: 12 months
Osteoporosis Knowledge
An osteoporosis knowledge test, using a scale, out of 30.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start10 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Western University, Canada
- Responsible party
- Principal investigator, Joy MacDermid, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997682
- Sponsor's protocol ID
- 114095
- Status last verified
- Feb 2021
- First submitted
- 10 Jun 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be made publicly available. Only de-identified data will be shared.
Publications
Ziebart C, MacDermid J, Bryant D, Szekeres M, Suh N. Hands-Up program: protocol for a feasibility randomised controlled trial of a combined 6-week exercise and education intervention in adults aged 50-65 with a distal radius fracture. BMJ Open. 2021 Jul 30;11(7):e046122. doi: 10.1136/bmjopen-2020-046122.
PubMed 34330854
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03997682
- Acronym / sponsor ID
- 114095
- Conditions
- Distal Radius Fracture, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Western University, Canada
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis is a bone disease that increases the risk of fractures. People aged 50-65 diagnosed with osteoporosis feel too young to have the disease. But this happens. They need to learn how to modify their lifestyle to minimize the chances of fractures. In this age group, a wrist fracture is usually the first sign of osteoporosis. Fracture risk increases if they are not taught to exercise, eat properly, and identifies fall risk factors early in their diagnosis. Some studies have looked at interventions for osteoporosis in women over the age of 65, but by this age they have likely already had a spine fracture. No studies have addressed the early-onset osteoporosis age group, intervening before spine fractures occur. I will develop an exercise, nutrition, and falls prevention education program to improve the strength, balance and knowledge of people aged 50-65 who had an osteoporotic wrist fracture. I will use this treatment approach and determine if it is more effective than the usual way of treating people with wrist fractures, determining if this is a better strategy for managing osteoporosis. I will have two groups of patients. First, those, over six weeks, receive twice weekly classes that include exercise and education. Here the focus is on bone health and fracture prevention. The control will receive usual physical therapy and the educational materials at the end of their study participation. The treatment will be randomly allocated to 74 men and women between the ages of 50-65 years of age who are 6-10 weeks post-fracture. The outcomes on both groups will be assessed and compared. I will focus on hand function, balance, fall hazard detection, and a bone health behaviour checklist. Using these outcomes, I can determine which treatment approach works best. Osteoporosis affects one in three women and one in five men, making this an important study to improve the lives for many Canadians. The risk of osteoporosis fractures increases with age, making early interventions critical.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands-Up Program | Experimental | Other: Hands-Up ProgramParticipants 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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Any contraindications to exercise
- Progressive neurological disorders that would affect study participation
- Unable to stand or walk independently
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hands-Up ProgramIn 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. | Other | Hands-Up Program |
Primary outcome
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
4 secondary outcomes
Grip Strength
Time frame: 12 months
Patient Rated Wrist Evaluation
Time frame: 12 months
Bone Density
Time frame: 12 months
Osteoporosis Knowledge
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 34330854Ziebart C, MacDermid J, Bryant D, Szekeres M, Suh N. Hands-Up program: protocol for a feasibility randomised controlled trial of a combined 6-week exercise and education intervention in adults aged 50-65 with a distal radius fracture. BMJ Open. 2021 Jul 30;11(7):e046122. doi: 10.1136/bmjopen-2020-046122.
- Individual participant dataSharing planned: No. The individual participant data will not be made publicly available. Only de-identified data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands-Up Program in people with Distal Radius Fracture and Osteoporosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joy C MacDermid, PhD (519-646-6100 ext. 64636, jmacderm@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.