Functional Exercise and Nutrition Education Program for Older Adults

Not Applicable

Completed

Conditions: Cardiovascular Diseases
Kidney Diseases
Frail
Diabetes Mellitus
Cancer
Stroke
Chronic Lung Disease
Osteoporosis, Osteopenia
Chronic Disease
Congestive Heart Failure

Interventions: Other: Usual Care
Other: Strength and Balance Training & Nutrition Education

Registration Number: NCT04037436

Lead Sponsor: University of Waterloo

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Usual Care	Each cluster contributes observations under both control and intervention observation periods.
Intervention	Strength and Balance Training & Nutrition Education	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.

Primary Outcome Measures

Name	Time	Method
Feasibility - Recruitment	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	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	16 sessions	Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher.

Secondary Outcome Measures

Name	Time	Method
Body Weight	Baseline	We will measure body weight with a calibrated scale.
10 Meter Walk Test	Mean change from follow up (study visit 4) and baseline	Fried Frailty Index Components: walking speed via the 10-meter walk test protocol.
Grip Strength	Mean change from follow up (study visit 4) and baseline	Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer
30 Second Chair Stand Test	Mean change from follow up (study visit 4) and baseline	We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance.
4 Square Step Test	Mean change from follow up (study visit 4) and baseline	The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls
EuroQol 5 Dimension Version 5-level (EQ-5D-5L)	Mean change from follow up (study visit 4) and baseline	The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better. The scores on the subscales are given weights and summed to convert the scores to one index score. The range of possible scores for the EQ-5D-5L index is from -0.573 to 1. A higher score is better.
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	Mean change from follow up (study visit 4) and baseline	We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section
Number of Participants With Adverse Events	Study visit 1, 2, 3 and 4	We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section
Participant and Provider Experience	study visit 4	We used a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section.

Trial Locations

Locations (5): Chaplin Family YMCA
🇨🇦
Cambridge, Ontario, Canada
Village of Winston Park
🇨🇦
Kitchener, Ontario, Canada
Your Family Health Team
🇨🇦
Sudbury, Ontario, Canada
A.R. Kaufman Family YMCA
🇨🇦
Kitchener, Ontario, Canada
The Village of Arbour Trails
🇨🇦
Guelph, Ontario, Canada