Clinical trial NCT01698463: Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach
Official title: Tailored Exercise for Fall and Fracture Prevention in Older Adults: A Family Health Team Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall and Fractures Prevention
Keywords: Falls, Fractures, Osteoporosis, Frailty, Older Adults.
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: The Centre for Family Medicine, Ontario
First posted: 2012-10-03
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Falls and fractures are a leading cause of death and disability in the older adult population. The consequences of falls and fractures contribute substantially to health care costs and can have a significant negative impact on the quality of life of the individual. Exercise has been studied as an option to reduce fracture risk and prevent falls though improving balance and muscle strength. The prevention of falls is important, as a history of falls is strongly predictive of suffering another. Those who are at a high risk of fracture or falling require a patient specific assessment and individualized exercise prescription that is tailored to their needs. This kind of program may not be typically available within the community and at a low cost. These individuals may experience difficulty when trying to engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge. As the first point of contact with the health care system for many family doctors are in the ideal position to deliver exercise advice to their patients. However, a lack of time and specialized skills in prescribing exercise make this difficult for many of them. As a result, family health teams who provide interdisciplinary patient centered care are becoming popular. In this model the care is shared and provided by the most appropriate team member (e.g. doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include a behavior change aspect, which may be an important component when trying to get individuals to engage in a new health behavior like exercise. Therefore the purpose of this project is to assess the feasibility of implementing a tailored exercise program to those at high risk of falls or fractures over the age of 65 in a primary care setting using an interdisciplinary model of care that is based on a health behaviour change model.

Detailed description: Falls and fractures together represent one of the leading causes of morbidity and mortality within the older adult population. Additionally, the consequences of falls and fractures contribute substantial costs to the health care system and negatively impact the quality of life of the individual. Given that Canada's aging population in increasing at an unprecedented rate, it is imperative that the prevention and management of falls and fractures is made a priority. One such population particularly vulnerable to falls and fractures are those diagnosed with osteoporosis or low bone mass.

It has been estimated that approximately 10 billion individuals have been diagnosed with osteoporosis and another 34 million are at risk with low bone mass. Osteoporosis-related fragility fractures are a common consequence of osteoporosis and result in increased morbidity and mortality. Approximately 50% of those who suffer a hip fracture do not regain their previous level of mobility and functional independence thus resulting in many of these individuals relying on the use of assistive devices.

Currently the emphasis of osteoporosis treatment and management is to prevent the occurrence of fragility fractures and the subsequent side effects that accompany them. A recent meta-analysis has shown that exercise can assist in the prevention and maintenance of bone loss in postmenopausal women. Other benefits of exercise such as increases in muscle strength and balance have been strongly established to indirectly prevent fractures through a reduction in falls risk. Those who are at a high risk of falls or fracture require patient specific assessment and individualized prescription that is not typically available within the community or at a low cost. Further, it may be difficult to engage these individuals if they have spent most of their life in a sedentary state and experience barriers such as a lack of transportation, and a lack of knowledge on appropriate types of exercise or how to initiate exercise into their daily living. Furthermore, many exercises may not be appropriate for all individuals depending on location of fracture and level of physical function. It has been emphasized that the focus should be on an individualized exercise program, which would encompass individual needs while recognizing individual limitations.

Family physicians may be in an ideal position to deliver an exercise prescription to a patient, as they are often the first point of contact with the health care system. However, there have been a number of problems cited with using family physicians to implement the delivery of an exercise prescription. Among those barriers, a lack of time and a lack of knowledge have been identified as the most problematic. An interdisciplinary family health team model of care is becoming increasingly important in regards to the treatment of chronic conditions such as osteoporosis. Family health teams provide an ideal form of care where team members work together to deliver the program and enhance adherence.

A limitation of many exercise interventions is that they fail to include a behavior change component which may be an important factor to consider when attempting to facilitate adherence to an exercise program. The Health Action Process Approach is a model of behavior change that has been widely used in a variety of health contexts including but not limited to physical activity. The rationale for the selection of this model is that it incorporates key principles of other behavior change models. Furthermore, the model has been cited as being a valid and reliable tool for predicting physical activity levels in older adults.

This project outlines an exercise intervention that is multidisciplinary in nature and tailored to the individual to be employed within an interdisciplinary family health team. Additionally, a behavior change component is built into this intervention with key principles such as action planning and coping planning that are based on the HAPA model to facilitate the uptake of physical activity in this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* \> age 65
* Patient of the Centre for Family Medicine Family Health Team (CFFM FHT)

Have at least one of the following:

* 2 or more falls in the past 12 months
* age 75 +
* high risk of fracture based on the CAROC
* difficulty with walking or balance as determined by attending physician
* acute fall
* history of a fragility fracture after the age of 50

Exclusion Criteria:

* moderate to severe cognitive impairment
* moderate to severe neurologic impairment
* not able to communicate in English
* contraindications to exercise as determined by physician
* uncontrolled hypertension
* palliative care, current cancer, on dialysis
* participation in a similar exercise program including resistance training at least 3 times a week

Primary outcomes:
measure: Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)
timeFrame: Baseline, 6 week follow-up
measure: Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)
timeFrame: Baseline, 6 week follow-up
Secondary outcomes:
measure: Behavior Change Outcome: Action Planning
timeFrame: Baseline, 6 week follow-up
measure: Behavior Change Outcome: Coping Planning
timeFrame: Baseline, 6 week follow-up
measure: Behavior Change Outcome: Coping Self-Efficacy
timeFrame: Baseline, 6 week follow-up
measure: Behavior Change Outcome: Intentions
timeFrame: Baseline, 6 week follow-up
measure: Health Related Quality of Life (HRQOL)
timeFrame: Baseline, 6 week follow-up
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Centre for Family Medicine (CFFM)
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lora M Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
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