Clinical trial NCT02266225: Measuring the Implementation of the LiFE Program in Primary Care for Older Adults Aged 75 Years or Older
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Chronic disease management
Physical activity
Fall prevention
Strength and balance exercise
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2014-10-16
Enrollment: 48
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Physical activity has numerous health and functional benefits for older adults, including increased lifespan, performing daily activities better, and improving quality of life. However, engaging older adults with multiple chronic diseases in traditional exercise programs is challenging. Community exercise programs may not meet the needs of frail older adults or be accessible because of physical limitations or travel required. Although structured, supervised exercise can be effective, it may not be realistic to implement on a population-wide basis. Although there is substantial evidence demonstrating that exercise can improve multiple health outcomes, there is limited research defining how exercise should be implemented in practice to engage older adults with chronic diseases.

Declines in person-centered outcomes (e.g., function, quality of life) and an increased risk of falls, cardiovascular events, and fractures occur with aging and may be amenable to interventions. Primary care is an ideal setting for identifying elderly patients in need of exercise intervention. However, a cost-effective, generalizable model of chronic disease management for older adults using exercise in this setting remains elusive. Further, the delivery of individualized exercise prescription for all older adults may not be feasible.

A recent study demonstrated that teaching older adults to integrate exercise into daily life activities was effective for reducing falls and improving function in older adult fallers. In addition, there is evidence that integrating balance and strength exercises into activities of daily living may promote long-term exercise participation, by "instituting new habitual behaviors within selected situational contexts that serve as prompts for action" . Therefore, the proposed physiotherapist-led group-based lifestyle-integrated functional exercise intervention delivered in primary care is timely. Recently announced changes to funding will allow physiotherapists to work within family health teams. However, there are no guidelines for how physiotherapy resources should be allocated.

This pilot feasibility study will evaluate how we can use these resources efficiently for chronic disease management in older adults via a novel intervention that teaches them lifestyle-integrated therapeutic exercise. The long-term aim is to improve the capacity for care providers in an interdisciplinary setting to offer patient-centered care that includes exercise to older adults 75 years or older. Thus, we propose to evaluate the pragmatic implementation of a group-based intervention in primary care that teaches older adults to integrate functional balance and strength exercises into daily activities as a relevant strategy, also known as the Lifestyle-integrated Functional Exercise (LiFE) program. The LiFE program is proposed as a strategy to engage older adults in sustainable exercise participation to improve chronic disease management and quality of life.

Our research objectives are related to feasibility, retention, and adherence and include: (1) to evaluate the number of participants we can recruit over 6 months: The intervention will be considered feasible if we recruit 32 participants over 6 months. Data collected from a screening program at the Centre for Family Medicine over 6 months shows that we have recruited 198 individuals who were not regularly exercising and 59 of those individuals agreed to receive information about exercise. Recruitment of 32 participants at one site over 6 months translates to 576 participants with 3 sites in three years; (2) to determine intervention retention rates: The intervention will be considered feasible if 75% of the sample complete the 6 month follow-up assessments; 3) to determine adherence to the exercise intervention: The intervention will be considered feasible if 50% of the participants complete balance and strength activities ≥3 days per week over the 6 month study period. Our criteria are based on randomized controlled trial data in exercise and falls prevention research showing that the completion of balance and strength exercise ≥ 3 times per week was positively associated with fall outcomes. In another study, the mean number of days in which the balance and strength activities were completed per week in the final month of the LiFE program was 3.89 of a maximum 7 days. Notably, a 47% adherence to the LiFE program over the first 6 months was associated with clinically relevant reduction in the rate of falls (31%).The secondary research questions will address other process outcomes to inform a larger trial and evaluate the effectiveness of the intervention on physical activity levels, physical performance, and quality of life.

Eligibility 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).

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
measure: Adherence (Including Withdrawals)
timeFrame: 6 months
Secondary outcomes:
measure: Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week)
timeFrame: Baseline, 6 months
measure: Change in Physical Performance- Scores on the Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 6 months
measure: Change in Quality of Life- EQ5D Dimensions and VAS Score
timeFrame: Baseline, 6 months
measure: Number of Falls
timeFrame: 6 months
measure: Number of Participants With Falls
timeFrame: 6 months
measure: Number of Participants With Multiple Falls
timeFrame: 6 months
measure: Number of Participants With Adverse Events or Injuries (Serious or Otherwise)
timeFrame: 6 months
measure: Average Scores on Fidelity Rating Form - Individual and Group Sessions
timeFrame: 6 months
measure: Sum of Scores on Fidelity Rating Forms - Individual and Group Sessions
timeFrame: 6 months
measure: Number of Participants Who Provided Feedback on the Barriers and Facilitators to the Implementation of the Exercise Program
timeFrame: 6 months
measure: Change in TFEQ-R21 Score- Cognitive Restraint Subscale
timeFrame: Baseline, 6 months
measure: Change in TFEQ-R21 Score - Uncontrolled Eating Subscale
timeFrame: Baseline, 6 months
measure: Change in TFEQ-R21 Score - Emotional Eating Behaviour Subscale
timeFrame: Baseline, 6 months
Other outcomes:
measure: Session Attendance
timeFrame: 6 months
Locations:
city: Kitchener
country: Canada
facility: Centre for Family Medicine
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lora Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
References: