Functional Exercise and Nutrition Education Program for Older Adults (MoveStrong)

March 25, 2025 updated by: University of Waterloo

A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Cambridge, Ontario, Canada
        • Chaplin Family YMCA
      • Guelph, Ontario, Canada, N1G 0C9
        • The Village of Arbour Trails
      • Kitchener, Ontario, Canada, N2G 3C5
        • A.R. Kaufman Family YMCA
      • Kitchener, Ontario, Canada, N2E 3K1
        • Village of Winston Park
      • Sudbury, Ontario, Canada, P3A 2T4
        • Your Family Health Team

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks.
Other: Control
Each cluster contributes observations under both control and intervention observation periods.
During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of the program to 9 weeks
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.
2 month (September to October 2019)
Feasibility - Adherence
Time Frame: 16 sessions

Definition: Percentage of individuals that attended exercise and nutrition sessions.

The criterion for success is 70% or higher.

16 sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline
We will measure body weight with a calibrated scale.
Baseline
10 Meter Walk Test
Time Frame: Mean change from follow up (study visit 4) and baseline
Fried Frailty Index Components: walking speed via the 10-meter walk test protocol.
Mean change from follow up (study visit 4) and baseline
Grip Strength
Time Frame: Mean change from follow up (study visit 4) and baseline
Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer
Mean change from follow up (study visit 4) and baseline
30 Second Chair Stand Test
Time Frame: 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.
Mean change from follow up (study visit 4) and baseline
4 Square Step Test
Time Frame: 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
Mean change from follow up (study visit 4) and baseline
EuroQol 5 Dimension Version 5-level (EQ-5D-5L)
Time Frame: 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.
Mean change from follow up (study visit 4) and baseline
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time Frame: 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
Mean change from follow up (study visit 4) and baseline
Number of Participants With Adverse Events
Time Frame: 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
Study visit 1, 2, 3 and 4
Participant and Provider Experience
Time Frame: 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.
study visit 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

March 14, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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