Clinical trial NCT04037436: Functional Exercise and Nutrition Education Program for Older Adults
Official title: A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Frail
Diabetes Mellitus
Cancer
Chronic Lung Disease
Cardiovascular Diseases
Congestive Heart Failure
Hypertension
Osteoporosis, Osteopenia
Arthritis
Stroke
Kidney Diseases
Keywords: Strength Training
Balance Training
Nutrition Education
Older adults
Frailty
Feasibility
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: City of Lakes family Health Team
name: Schlegel-UW Research Institute for Aging
name: YMCA
First posted: 2019-07-30
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We will use a closed cohort stepped wedge design at 4 sites (1 in Northern Ontario and 3 in Southern Ontario). In a stepped wedge, sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.
Primary purpose: OTHER

Brief summary: There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.

Detailed description: The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.

Eligibility criteria: Inclusion Criteria:

* Speak English or attend with a translator;
* ≥ 60 years;
* FRAIL scale score ≥1;
* Have ≥1 diagnosed chronic condition (i.e., diabetes, obesity, cancer (other than minor skin cancer), chronic lung disease, cardiovascular disease, congestive heart failure, hypertension, osteoporosis, arthritis, stroke, or kidney disease).

Exclusion Criteria:

* Currently doing similar resistance exercise ≥2x/week;
* In palliative care;
* Not able to perform basic activities of daily living;
* Cognitive impairment (e.g., unable to follow two-step commands);
* Travelling \>1 week during exposure;
* Absolute exercise contraindications (i.e., if they select "no" to any question in the Get Active Questionnaire they must seek physician approval before exercising)

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: 2 month (September to October 2019)
measure: Feasibility - Retention
timeFrame: Start of the program to 9 weeks
measure: Feasibility - Adherence
timeFrame: 16 sessions
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline
measure: 10 Meter Walk Test
timeFrame: Mean change from follow up (study visit 4) and baseline
measure: Grip Strength
timeFrame: Mean change from follow up (study visit 4) and baseline
measure: 30 Second Chair Stand Test
timeFrame: Mean change from follow up (study visit 4) and baseline
measure: 4 Square Step Test
timeFrame: Mean change from follow up (study visit 4) and baseline
measure: EuroQol 5 Dimension Version 5-level (EQ-5D-5L)
timeFrame: Mean change from follow up (study visit 4) and baseline
measure: Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
timeFrame: Mean change from follow up (study visit 4) and baseline
measure: Number of Participants With Adverse Events
timeFrame: Study visit 1, 2, 3 and 4
measure: Participant and Provider Experience
timeFrame: study visit 4
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Chaplin Family YMCA
state: Ontario
city: Guelph
country: Canada
facility: The Village of Arbour Trails
state: Ontario
city: Kitchener
country: Canada
facility: Village of Winston Park
state: Ontario
city: Kitchener
country: Canada
facility: A.R. Kaufman Family YMCA
state: Ontario
city: Sudbury
country: Canada
facility: Your Family Health Team
state: Ontario
Study officials:
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