- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037436
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
Status
Completed
Conditions
Intervention / Treatment
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
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Cambridge, Ontario, Canada
- Chaplin Family YMCA
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Guelph, Ontario, Canada, N1G 0C9
- The Village of Arbour Trails
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Kitchener, Ontario, Canada, N2G 3C5
- A.R. Kaufman Family YMCA
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Kitchener, Ontario, Canada, N2E 3K1
- Village of Winston Park
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Sudbury, Ontario, Canada, P3A 2T4
- Your Family Health Team
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-
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.
|
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Other: Control
Each cluster contributes observations under both control and intervention observation periods.
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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.
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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.
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Start of the program to 9 weeks
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Feasibility - Recruitment
Time Frame: 2 month (September to October 2019)
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Definition: Number recruited at end of rollout.
The criterion for success is to recruit 10 participants at each of 4 sites.
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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.
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Baseline
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10 Meter Walk Test
Time Frame: Mean change from follow up (study visit 4) and baseline
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Fried Frailty Index Components: walking speed via the 10-meter walk test protocol.
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Mean change from follow up (study visit 4) and baseline
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Grip Strength
Time Frame: Mean change from follow up (study visit 4) and baseline
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Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer
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Mean change from follow up (study visit 4) and baseline
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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.
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Mean change from follow up (study visit 4) and baseline
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4 Square Step Test
Time Frame: Mean change from follow up (study visit 4) and baseline
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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
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Mean change from follow up (study visit 4) and baseline
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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.
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Mean change from follow up (study visit 4) and baseline
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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
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Mean change from follow up (study visit 4) and baseline
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Number of Participants With Adverse Events
Time Frame: Study visit 1, 2, 3 and 4
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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
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Study visit 1, 2, 3 and 4
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Participant and Provider Experience
Time Frame: study visit 4
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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.
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study visit 4
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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
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.
- Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
- Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.
- Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
- Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21.
- Borde R, Hortobagyi T, Granacher U. Dose-Response Relationships of Resistance Training in Healthy Old Adults: A Systematic Review and Meta-Analysis. Sports Med. 2015 Dec;45(12):1693-720. doi: 10.1007/s40279-015-0385-9.
- Ravindran AV, Balneaves LG, Faulkner G, Ortiz A, McIntosh D, Morehouse RL, Ravindran L, Yatham LN, Kennedy SH, Lam RW, MacQueen GM, Milev RV, Parikh SV; CANMAT Depression Work Group. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 5. Complementary and Alternative Medicine Treatments. Can J Psychiatry. 2016 Sep;61(9):576-87. doi: 10.1177/0706743716660290. Epub 2016 Aug 2.
- Beaudart C, Rizzoli R, Bruyere O, Reginster JY, Biver E. Sarcopenia: burden and challenges for public health. Arch Public Health. 2014 Dec 18;72(1):45. doi: 10.1186/2049-3258-72-45. eCollection 2014.
- Brosseau L, Wells GA, Poitras S, Tugwell P, Casimiro L, Novikov M, Loew L, Sredic D, Clement S, Gravelle A, Kresic D, Hua K, Lakic A, Menard G, Sabourin S, Bolduc MA, Ratte I, McEwan J, Furlan AD, Gross A, Dagenais S, Dryden T, Muckenheim R, Cote R, Pare V, Rouhani A, Leonard G, Finestone HM, Laferriere L, Haines-Wangda A, Russell-Doreleyers M, De Angelis G, Cohoon C. Ottawa Panel evidence-based clinical practice guidelines on therapeutic massage for low back pain. J Bodyw Mov Ther. 2012 Oct;16(4):424-55. doi: 10.1016/j.jbmt.2012.04.002. Epub 2012 Jun 23.
- Giangregorio LM, Papaioannou A, Macintyre NJ, Ashe MC, Heinonen A, Shipp K, Wark J, McGill S, Keller H, Jain R, Laprade J, Cheung AM. Too Fit To Fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteoporos Int. 2014 Mar;25(3):821-35. doi: 10.1007/s00198-013-2523-2. Epub 2013 Nov 27.
- Peterson MD, Sen A, Gordon PM. Influence of resistance exercise on lean body mass in aging adults: a meta-analysis. Med Sci Sports Exerc. 2011 Feb;43(2):249-58. doi: 10.1249/MSS.0b013e3181eb6265.
- Trombetti A, Hars M, Hsu FC, Reid KF, Church TS, Gill TM, King AC, Liu CK, Manini TM, McDermott MM, Newman AB, Rejeski WJ, Guralnik JM, Pahor M, Fielding RA; LIFE Study Investigators. Effect of Physical Activity on Frailty: Secondary Analysis of a Randomized Controlled Trial. Ann Intern Med. 2018 Mar 6;168(5):309-316. doi: 10.7326/M16-2011. Epub 2018 Jan 9.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Bone Diseases
- Musculoskeletal Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Disease Attributes
- Metabolic Diseases
- Respiratory Tract Diseases
- Heart Failure
- Lung Diseases
- Cardiovascular Diseases
- Osteoporosis
- Kidney Diseases
- Bone Diseases, Metabolic
- Chronic Disease
Other Study ID Numbers
- 20190401
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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