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Completed

NCT Number: NCT04037436

Functional Exercise and Nutrition Education Program for Older Adults

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.

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Key information

Conditions

Chronic Disease Arthritis Bone Diseases Bone Diseases, Metabolic Brain Diseases Cancer Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Lung Disease Congestive Heart Failure Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frail Frailty Glucose Metabolism Disorders Heart Diseases Heart Failure Hypertension Joint Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Osteopenia Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chaplin Family YMCA, Cambridge, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Strength and Balance Training & Nutrition Education

Other

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.

Usual Care

Other

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.

Primary outcomes

  1. 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. 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.

  3. 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

  1. Body Weight

    Time frame: Baseline

    We will measure body weight with a calibrated scale.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • City of Lakes family Health Team
  • Schlegel-UW Research Institute for Aging
  • YMCA

Registry information

Official study title

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

Acronym: MoveStrong

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2019
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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