Fall and Fractures Prevention Clinical Trial
— PEPTEAMOfficial title:
Tailored Exercise for Fall and Fracture Prevention in Older Adults: A Family Health Team Approach
NCT number | NCT01698463 |
Other study ID # | 17664 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | July 2012 |
Verified date | November 2017 |
Source | University of Waterloo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | July 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Family Medicine (CFFM) | Kitchener | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Waterloo | The Centre for Family Medicine, Ontario |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity (Reporting Change in Physical Activity From Baseline to Six-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 | |
Primary | Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-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 | Behavior Change Outcome: Action Planning | 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 | |
Secondary | Behavior Change Outcome: Coping Planning | 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 | |
Secondary | Behavior Change Outcome: Coping Self-Efficacy | 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 | |
Secondary | Behavior Change Outcome: Intentions | 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 | |
Secondary | Health Related Quality of Life (HRQOL) | 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 |