Functional Exercise and Nutrition Education Program for Older Adults

NCT04037436 | Completed Results DMC

• 1 other identifier: 20190401
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (3)

• Feasibility - Recruitment

  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 - Retention

  Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.

  Start of the program to 9 weeks

• Feasibility - Adherence

  Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher.

  16 sessions

Secondary Outcomes (9)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Strength and Balance Training & Nutrition Education

Control

OTHER

Each cluster contributes observations under both control and intervention observation periods.

Other: Usual Care

Interventions

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.

Intervention

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.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (5)

Chaplin Family YMCA

Cambridge, Ontario, Canada

Location

Your Family Health Team

Greater Sudbury, Ontario, P3A 2T4, Canada

Location

The Village of Arbour Trails

Guelph, Ontario, N1G 0C9, Canada

Location

Village of Winston Park

Kitchener, Ontario, N2E 3K1, Canada

Location

A.R. Kaufman Family YMCA

Kitchener, Ontario, N2G 3C5, Canada

Location

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• Wang E, Keller H, Mourtzakis M, Rodrigues IB, Steinke A, Ashe MC, Thabane L, Brien S, Funnell L, Cheung AM, Milligan J, Papaioannou A, Weston ZJ, Straus S, Giangregorio L. MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. Appl Physiol Nutr Metab. 2022 Dec 1;47(12):1172-1186. doi: 10.1139/apnm-2022-0195. Epub 2022 Sep 15.

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• Rodrigues IB, Wagler JB, Keller H, Thabane L, Weston ZJ, Straus SE, Papaioannou A, Mourtzakis M, Milligan J, Isaranuwatchai W, Loong D, Jain R, Funnell L, Cheung AM, Brien S, Ashe MC, Giangregorio LM. Encouraging older adults with pre-frailty and frailty to "MoveStrong": an analysis of secondary outcomes for a pilot randomized controlled trial. Health Promot Chronic Dis Prev Can. 2022 Jun;42(6):238-251. doi: 10.24095/hpcdp.42.6.02.

  PMID: 35766913 RESULT

• Rodrigues IB, Wang E, Keller H, Thabane L, Ashe MC, Brien S, Cheung AM, Funnell L, Jain R, Loong D, Isaranuwatchai W, Milligan J, Mourtzakis M, Papaioannou A, Straus S, Weston ZJ, Giangregorio LM. The MoveStrong program for promoting balance and functional strength training and adequate protein intake in pre-frail older adults: A pilot randomized controlled trial. PLoS One. 2021 Sep 24;16(9):e0257742. doi: 10.1371/journal.pone.0257742. eCollection 2021.

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MeSH Terms

Conditions

Chronic Disease; Diabetes Mellitus; Neoplasms; Cardiovascular Diseases; Heart Failure; Hypertension; Osteoporosis; Bone Diseases, Metabolic; Arthritis; Stroke; Kidney Diseases; Frailty

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Vascular Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: The MoveStrong program for promoting balance and functional strength training and adequate protein i
• Organization: University of Waterloo

lmgiangr@uwaterloo.ca

519-888-4567

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Outcomes Assessor)
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 30, 2019
• Study Start: September 24, 2019
• Primary Completion: March 14, 2020
• Study Completion: September 1, 2020
• Last Updated: April 13, 2025
• Results First Posted: April 13, 2025

Record last verified: 2022-11

Locations

CA (5)