A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Waterloo
- Enrollment
- 44
- Locations
- 5
- Primary Endpoint
- Feasibility - Recruitment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention
At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.
Intervention: Strength and Balance Training & Nutrition Education (Other)
Control
Each cluster contributes observations under both control and intervention observation periods.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Feasibility - Recruitment
Time Frame: 2 month (September to October 2019)
Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.
Feasibility - Retention
Time Frame: Start of the program to 9 weeks
Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.
Feasibility - Adherence
Time Frame: 16 sessions
Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher.
Secondary Outcomes
- Body Weight(Baseline)
- 10 Meter Walk Test(Mean change from follow up (study visit 4) and baseline)
- Grip Strength(Mean change from follow up (study visit 4) and baseline)
- 30 Second Chair Stand Test(Mean change from follow up (study visit 4) and baseline)
- 4 Square Step Test(Mean change from follow up (study visit 4) and baseline)
- EuroQol 5 Dimension Version 5-level (EQ-5D-5L)(Mean change from follow up (study visit 4) and baseline)
- Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool(Mean change from follow up (study visit 4) and baseline)
- Number of Participants With Adverse Events(Study visit 1, 2, 3 and 4)
- Participant and Provider Experience(study visit 4)