Trial Outcomes & Findings for Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach (NCT NCT01698463)
NCT ID: NCT01698463
Last Updated: 2019-02-18
Results Overview
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.
COMPLETED
NA
11 participants
Baseline, 6 week follow-up
2019-02-18
Participant Flow
No pre-assignment of participants to groups.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=11 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=11 Participants
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Age, Categorical
>=65 years
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11 Participants
n=11 Participants
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Sex: Female, Male
Female
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10 Participants
n=11 Participants
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Sex: Female, Male
Male
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1 Participants
n=11 Participants
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Region of Enrollment
Canada
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11 Participants
n=11 Participants
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Sedentary
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546.2 min/day
STANDARD_DEVIATION 274.7 • n=11 Participants
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Low Light Physical Activity
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211.3 min/day
STANDARD_DEVIATION 100.0 • n=11 Participants
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High Light Physical Activity
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32.8 min/day
STANDARD_DEVIATION 24.4 • n=11 Participants
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Moderate to Vigorous Physical Activity
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24.7 min/day
STANDARD_DEVIATION 22.8 • n=11 Participants
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Short Physical Performance Battery
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7.91 units on a scale
STANDARD_DEVIATION 3.02 • n=11 Participants
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Timed Up and Go (TUG)
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13.95 seconds
STANDARD_DEVIATION 6.12 • n=11 Participants
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Coping Planning
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10.45 units on a scale
STANDARD_DEVIATION 3.93 • n=11 Participants
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Action Planning
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16.45 units on a scale
STANDARD_DEVIATION 5.66 • n=11 Participants
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Coping Self-Efficacy
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32.55 units on a scale
STANDARD_DEVIATION 6.59 • n=11 Participants
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Intentions
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11.73 units on a scale
STANDARD_DEVIATION 2.20 • n=11 Participants
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EQ-5D-5L (HRQOL)
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7.05 units on a scale
STANDARD_DEVIATION 1.19 • n=11 Participants
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PRIMARY outcome
Timeframe: Baseline, 6 week follow-upThe 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.
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)
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21.6 minutes/day
Standard Deviation 15.8
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PRIMARY outcome
Timeframe: Baseline, 6 week follow-upParticipants 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.
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)
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65.7 percentage of completed exercise
Standard Deviation 23.2
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SECONDARY outcome
Timeframe: Baseline, 6 week follow-upA 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).
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Behavior Change Outcome: Action Planning
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21.00 units on a scale
Standard Deviation 1.79
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SECONDARY outcome
Timeframe: Baseline, 6 week follow-upA 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).
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Behavior Change Outcome: Coping Planning
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14.55 units on a scale
Standard Deviation 1.92
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SECONDARY outcome
Timeframe: Baseline, 6 week follow-upA 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).
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Behavior Change Outcome: Coping Self-Efficacy
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34.45 units on a scale
Standard Deviation 4.11
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SECONDARY outcome
Timeframe: Baseline, 6 week follow-upA 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).
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Behavior Change Outcome: Intentions
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12.0 units on a scale
Standard Deviation 1.61
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SECONDARY outcome
Timeframe: Baseline, 6 week follow-upThe 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).
Outcome measures
| Measure |
Identify Patients at Risk/Exercise Prescription
n=11 Participants
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.
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.
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|---|---|
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Health Related Quality of Life (HRQOL)
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8.0 units on a scale
Standard Deviation 1.0
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Adverse Events
Identify Patients at Risk/Exercise Prescription
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place