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
1 other identifier
interventional
74
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedStudy Start
First participant enrolled
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedFebruary 25, 2021
February 1, 2021
12 months
June 10, 2019
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Feasibility of recruitment
Number of participants recruited in one year. Recruitment will be feasible if 74 participants are recruited within 12 months
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.
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
12 months
Secondary Outcomes (4)
Grip Strength
12 months
Patient Rated Wrist Evaluation
12 months
Bone Density
12 months
Osteoporosis Knowledge
12 months
Study Arms (2)
Hands-Up Program
EXPERIMENTALParticipants 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 INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any contraindications to exercise
- Progressive neurological disorders that would affect study participation
- Unable to stand or walk independently
- Unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Joseph Health Care
London, Ontario, N6A 4L6, Canada
Related Publications (1)
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.
PMID: 34330854DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 25, 2019
Study Start
March 10, 2021
Primary Completion
March 1, 2022
Study Completion
September 1, 2022
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
The individual participant data will not be made publicly available. Only de-identified data will be shared.