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Measuring the Implementation of the LiFE Program in Primary Care for Older Adults Aged 75 Years or Older (Mi-LIFE)

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ClinicalTrials.gov Identifier: NCT02266225
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Lora Giangregorio, University of Waterloo

Brief Summary:
The goal of this study is to evaluate how to implement an evidence-based lifestyle-integrated strength and balance exercise (LiFE) intervention in primary care to promote increased physical activity (PA) and improvements in function and quality of life in older adults 75 years or older. This study will evaluate the public health impact of the LiFE intervention using the RE-AIM model: reach (recruitment), effectiveness (PA levels), adoption (physician acceptance), implementation (fidelity), and maintenance (retention, adherence). If the intervention appears feasible, we will use the resultant information to design a larger pragmatic trial.

Condition or disease Intervention/treatment Phase
Chronic Disease Other: Lifestyle-integrated Functional Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measuring the Implementation of a Group-based Lifestyle-integrated Functional Exercise (Mi-LiFE) Intervention Delivered in Primary Care for Older Adults Aged 75 Years or Older: A Pilot Feasibility Study
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle-integrated functional exercise
Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.
Other: Lifestyle-integrated Functional Exercise
Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: 6 months ]
    Feasibility of recruitment is defined as the number of participants recruited (feasibility) over six months.

  2. Retention [ Time Frame: 6 months ]
    Retention is defined as the number of participants retained at Study Visit #1 (6-month follow-up).

  3. Adherence [ Time Frame: 6 months ]
    Adherence is defined as the number of days each week that the participant completes/integrates strength and balance activities into daily tasks. Adherence will be 100% if participants complete the balance and strength activities at least 3 days per week.


Secondary Outcome Measures :
  1. Change in physical activity- moderate-to-vigorous physical activity (minutes/week) [ Time Frame: Baseline, 6 months ]
    • Participants will wear a physical activity monitor (Actigraph accelerometer) for seven days following Study Visit #1 (baseline) and Study Visit #2 (6 month follow-up) to determine the number of minutes spent sedentary and in light, moderate, and moderate-to-vigorous physical activity.
    • Participants will complete the IPAQ at Study Visit #1 (baseline) and Study Visit #2 (6 month follow-up) to evaluate changes in self-reported time spent performing physical activity.

  2. Change in physical performance- composite SPPB score [ Time Frame: Baseline, 6 months ]
    Participants will complete physical performance tests as a measure of balance, mobility, and leg strength at Study Visits 1 (Baseline) and 2 (at 6 months). Specifically, the SPPB will be completed to measure gait speed in a 4 meter walk test, balance via timed static stance in eyes open, semi-tandem, and full-tandem positions and leg strength via the Five-Times-Sit-to-Stand test.

  3. Change in quality of life- EQ5D Dimensions and VAS score [ Time Frame: 6 months ]
    Health-related quality of life will be assessed using the EQ5D health questionnaire at Study Visits 1 (Baseline) and 2 (at 6 months) to determine scores for all five dimensions (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and the visual analogue scale (VAS).

  4. Barriers and facilitators to implementation [ Time Frame: 6 months ]
    Barriers/facilitators reported by research staff, CFFM team or participants during program implementation will be recorded throughout study conduct. Video-taped exercise sessions will be audited for self-reported barriers and facilitators. Participants will be interviewed in-person or by phone immediately following completion of exercise program and at month 6 follow-up to obtain feedback on program delivery and materials, and overall satisfaction/dissatisfaction with the program experience.

  5. Falls [ Time Frame: 6 months ]
    Falls (e.g., number of falls, number of multiple fallers, and the falls rate) will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an "a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level".

  6. Harms [ Time Frame: 6 months ]
    Participants will be instructed by the research coordinator and physiotherapist to report adverse events or injuries (serious or otherwise) to the research coordinator. Participants will be asked about illnesses or injuries at exercise sessions, follow-up phone calls, and Study Visit #2 (6 month follow-up). Intervention side effects (e.g., falls, fractures) and three types of adverse events will represent secondary outcomes (serious adverse events, adverse events possibly linked to the intervention, and adverse events that lead to study withdrawal or cessation of intervention).

  7. Fidelity [ Time Frame: 6 months ]
    Fidelity evaluation of video-taped exercise sessions for first and last cohorts in the intervention (all sessions for first and last 4-5 individuals forming a group) will be conducted. A rating of physiotherapist compliance and participant uptake and descriptive feedback will be obtained.

  8. Change in TFEQ-R21 scores- cognitive restraint, uncontrolled eating, and emotional eating scales [ Time Frame: 6 months ]
    The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients who do not exercise beyond moving around/walking during activities of daily living or exercise occasionally/during certain seasons more than others, and are interested in information about an exercise program offered by CFFM will be contacted about the study. To qualify for the study, patients must be: (i) 75 years or older, (ii) able to communicate in English (if unable to speak English, patient may qualify if a translator can attend program sessions and assist with completion of program materials), and (iii) able to give informed consent.

Exclusion Criteria:

Patients will be excluded if they: (i) currently participate in lower body muscle strengthening and balance exercise 3 or more times per week for 30 minutes or more, (ii) have a known diagnosis of dementia (those with mild cognitive impairment may be eligible if the can understand instructions or have a caregiver that can assist with the program) , (iii) have any significant lung disease, moderate to severe chronic obstructive pulmonary disease, and (iv) have contraindication(s) to exercise (e.g., uncontrolled hypertension).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266225


Locations
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Canada, Ontario
Centre for Family Medicine
Kitchener, Ontario, Canada, N2G4X6
Sponsors and Collaborators
University of Waterloo
McMaster University
Investigators
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Principal Investigator: Lora Giangregorio, PhD University of Waterloo

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Responsible Party: Lora Giangregorio, Associate Professor, University of Waterloo
ClinicalTrials.gov Identifier: NCT02266225     History of Changes
Other Study ID Numbers: 19377
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Lora Giangregorio, University of Waterloo:
Chronic disease management
Physical activity
Fall prevention
Strength and balance exercise

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes