Measuring the Implementation of the LiFE Program in Primary Care for Older Adults Aged 75 Years or Older

NCT02266225 | Completed Results DMC

• 1 other identifier: 19377
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Chronic disease management; Physical activity; Fall prevention; Strength and balance exercise

Outcome Measures

Primary Outcomes (3)

• Feasibility of Recruitment

  Feasibility of recruitment is defined as the number of participants recruited (feasibility) over six months.

  6 months

• Retention

  Retention is defined as the number of participants retained at Study Visit #1 (6-month follow-up).

  6 months

• Adherence (Including Withdrawals)

  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.

  6 months

Secondary Outcomes (13)

• Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week)

  Baseline, 6 months

• Change in Physical Performance- Scores on the Short Physical Performance Battery (SPPB)

  Baseline, 6 months

• Change in Quality of Life- EQ5D Dimensions and VAS Score

  Baseline, 6 months

• Number of Falls

  6 months

• Number of Participants With Falls

  6 months

Other Outcomes (1)

• Session Attendance

  6 months

Study Arms (1)

Lifestyle-integrated functional exercise

EXPERIMENTAL

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

Interventions

Lifestyle-integrated Functional Exercise OTHER

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.

Lifestyle-integrated functional exercise

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Waterloo: lead
• McMaster University: collaborator

Study Sites (1)

Centre for Family Medicine

Kitchener, Ontario, N2G4X6, Canada

Location

MeSH Terms

Conditions

Chronic Disease; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Lora Giangregorio
• Organization: University of Waterloo

lora.giangregorio@uwaterloo.ca

519-888-4567

Study Officials

• Lora Giangregorio, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: October 16, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 26, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-08

Locations

CA (1)