NCT01698463

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

August 30, 2012

Results QC Date

June 14, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

Falls, Fractures, Osteoporosis, Frailty, Older Adults.

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Behavior Change Outcome: Action Planning

    Baseline, 6 week follow-up

  • Behavior Change Outcome: Coping Planning

    Baseline, 6 week follow-up

  • Behavior Change Outcome: Coping Self-Efficacy

    Baseline, 6 week follow-up

  • Behavior Change Outcome: Intentions

    Baseline, 6 week follow-up

  • Health Related Quality of Life (HRQOL)

    Baseline, 6 week follow-up

Study Arms (1)

Identify Patients at Risk/Exercise Prescription

OTHER

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

Interventions

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.

Identify Patients at Risk/Exercise Prescription

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \> age 65
  • Patient of the Centre for Family Medicine Family Health Team (CFFM FHT)
  • Have at least one of the following:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Family Medicine (CFFM)

Kitchener, Ontario, N2G 1C5, Canada

Location

Related Publications (36)

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    PMID: 11420776BACKGROUND
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    PMID: 20940232BACKGROUND
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    PMID: 18602880BACKGROUND
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    PMID: 19370674BACKGROUND
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    PMID: 10718694BACKGROUND
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    BACKGROUND
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    PMID: 10695849BACKGROUND
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    PMID: 10776362BACKGROUND
  • Nupponen R. What is counseling all about--basics in the counseling of health-related physical activity. Patient Educ Couns. 1998 Apr;33(1 Suppl):S61-7. doi: 10.1016/s0738-3991(98)00010-x.

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    PMID: 10493287BACKGROUND
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MeSH Terms

Conditions

Fractures, BoneOsteoporosisFrailty

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Wounds and InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

Small sample size and short study duration. Use of accelerometers to objectively capture physical activity (not all activity is captured by the accelerometers) and use of self-report physical activity logs. Possible self motivated participants.

Results Point of Contact

Title
Dr. Lora Giangregorio
Organization
University of Waterloo

Study Officials

  • Lora M Giangregorio, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

October 3, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

February 18, 2019

Results First Posted

February 18, 2019

Record last verified: 2017-11

Locations