Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach (PEPTEAM)

This study has been completed.
Sponsor:
Collaborator:
The Centre for Family Medicine, Ontario
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01698463
First received: August 30, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Fall and Fracture Prevention.
Other: Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tailored Exercise for Fall and Fracture Prevention in Older Adults: A Family Health Team Approach

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Physical Activity (reporting change in physical activity from baseline to six-week follow-up) [ Time Frame: Baseline, 6 week follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Behavior Change Outcome: Action Planning [ Time Frame: Baseline, 6 week follow-up ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes

    The intervention was delivered in two visits and two follow-up phone calls.

    • 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.
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698463

Locations
Canada, Ontario
Centre for Family Medicine (CFFM)
Kitchener, Ontario, Canada, N2G 1C5
Sponsors and Collaborators
University of Waterloo
The Centre for Family Medicine, Ontario
Investigators
Principal Investigator: Lora M Giangregorio, PhD University of Waterloo
  More Information

Publications:
Statistics Canada. Estimates of population, by age group and sex for July 1, Canada, provinces and territories, annual (CANSIM Table 051-0001). Ottawa: Statistics Canada 2010.
Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, et al. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ 2010; 182(17):1864-1874.
Buman MP, Hekler EB, Haskell WL, Pruitt L, Conway TL, Cain KL, et al. Objective light-intensity physical activity associations with rated health in older adults. Am J Epidemiol 2010; 172(10):1155-1165.

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01698463     History of Changes
Other Study ID Numbers: 17664
Study First Received: August 30, 2012
Last Updated: October 2, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Waterloo:
Falls, Fractures, Osteoporosis, Frailty, Older Adults.

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014