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

October 10, 2018 updated by: University of Waterloo

Tailored Exercise for Fall and Fracture Prevention in Older Adults: A Family Health Team Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1C5
        • Centre for Family Medicine (CFFM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Identify Patients at Risk/Exercise Prescription
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 week follow-up
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. The percentage of prescribed exercises completed are reported (for e.g. if participants completed 2 of 3 prescribed exercise then the reported percentage would be 67%). Mean (SD) are reported.
Baseline, 6 week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 25 (best performance).
Baseline, 6 week follow-up
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. Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 20 (best performance).
Baseline, 6 week follow-up
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. Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 45 (best performance).
Baseline, 6 week follow-up
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. Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 15 (best performance).
Baseline, 6 week follow-up
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. 0 (represents best performance) to 25 (represents worst performance).
Baseline, 6 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Waterloo

Collaborators

The Centre for Family Medicine, Ontario

Investigators

  • Principal Investigator: Lora M Giangregorio, PhD, University of Waterloo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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