Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach (PEPTEAM)
|ClinicalTrials.gov Identifier: NCT01698463|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fall and Fracture Prevention.||Other: Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tailored Exercise for Fall and Fracture Prevention in Older Adults: A Family Health Team Approach|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
Other: Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes
- Physician identifies that the patient is at risk of falls or fractures
- Visit one: individualized exercise prescription by a physiotherapist.
- Visit two: motivational interviewing (behavioural counselling) by kinesiologist
- Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions.
The intervention was delivered in two visits and two follow-up phone calls.
- Physical Activity (reporting change in physical activity from baseline to six-week follow-up) [ Time Frame: Baseline, 6 week follow-up ]The X2-Mini accelerometer (Gulf Coast Data Concepts.,USA) is a three-dimensional sensor that is used to capture the activity levels of an individual. The accelerometer is worn on the hip of the participant for four days. The number of minutes that the individual spends in each exercise intensity category is acquired. Accelerometer thresholds make up four categories of activity: (1) sedentary; (2) low-light; (3) high-light; (4) moderate-vigorous. Activity monitors have been indicated as the most accurate means of measuring physical activity levels.
- Physical Activity (Self-report) (reporting change in physical activity from baseline to six-week follow-up) [ Time Frame: Baseline, 6 week follow-up ]Participants complete a physical activity log-book daily in order to document their completion of the prescribed exercises and list any additional activities that they may have been engaged in. Minutes of activity per day are reported.
- Behavior Change Outcome: Action Planning [ Time Frame: Baseline, 6 week follow-up ]
A psychometric questionnaire will assess action planning using a likert scale at baseline and 6 weeks follow-up.
Action Planning: when, where and how an individual will engage in the recommended exercise.
- Behavior Change Outcome: Coping Planning [ Time Frame: Baseline, 6 week follow-up ]
A psychometric questionnaire will assess coping planning using a likert scale at baseline and 6 weeks follow-up.
Coping Planning: assesses an individuals ability to overcome perceived barriers e.g. lack of time, poor weather.
- Behavior Change Outcome: Coping Self-Efficacy [ Time Frame: Baseline, 6 week follow-up ]
A psychometric questionnaire will assess coping self-efficacy using a likert scale at baseline and 6 weeks follow-up.
Coping Self-Efficacy: assesses an individuals belief in their ability to overcome barriers.
- Behavior Change Outcome: Intentions [ Time Frame: Baseline, 6 week follow-up ]
A psychometric questionnaire will assess intentions using a likert scale at baseline and 6 weeks follow-up.
Intentions: assesses an individuals intention to engage in recommended exercises.
- Health Related Quality of Life (HRQOL) [ Time Frame: Baseline, 6 week follow-up ]The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698463
|Centre for Family Medicine (CFFM)|
|Kitchener, Ontario, Canada, N2G 1C5|
|Principal Investigator:||Lora M Giangregorio, PhD||University of Waterloo|