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Chronic DiseaseMoveStrongNCT04037436

Functional Exercise and Nutrition Education Program for Older Adults

A study testing Strength and Balance Training & Nutrition Education in people with Chronic Disease and Frail, run by University of Waterloo at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Disease, Frail, Diabetes Mellitus
What is being tested?
Strength and Balance Training & Nutrition Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
5 sitesCanada
Study dates
24 Sep 2019to 1 Sep 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites
  • Chaplin Family YMCA

    Cambridge, Ontario

  • Your Family Health Team

    Greater Sudbury, Ontario, P3A 2T4

  • The Village of Arbour Trails

    Guelph, Ontario, N1G 0C9

  • Village of Winston Park

    Kitchener, Ontario, N2E 3K1

  • A.R. Kaufman Family YMCA

    Kitchener, Ontario, N2G 3C5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Strength and Balance Training & Nutrition Education, Usual Care
Keywords
Strength Training, Balance Training, Nutrition Education, Older adults, Frailty, Feasibility
Medical subject headings
Chronic Disease, Diabetes Mellitus, Neoplasms, Cardiovascular Diseases, Heart Failure, Hypertension, Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength and Balance Training & Nutrition EducationOther

    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 CareOther

    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.

Study groups in NCT04037436
Study groupRoleWhat they receive
InterventionExperimentalAt 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.
Receives: Other: Strength and Balance Training & Nutrition Education
ControlOtherEach cluster contributes observations under both control and intervention observation periods.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Recruitment

    Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.

    Measured: 2 month (September to October 2019)

  2. Feasibility - Retention

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

    Measured: Start of the program to 9 weeks

  3. Feasibility - Adherence

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

    The criterion for success is 70% or higher.

    Measured: 16 sessions

Secondary outcomes (8)
  1. Body Weight

    We will measure body weight with a calibrated scale.

    Measured: Baseline

  2. 10 Meter Walk Test

    Fried Frailty Index Components: walking speed via the 10-meter walk test protocol.

    Measured: Mean change from follow up (study visit 4) and baseline

  3. Grip Strength

    Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer

    Measured: Mean change from follow up (study visit 4) and baseline

  4. 30 Second Chair Stand Test

    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.

    Measured: Mean change from follow up (study visit 4) and baseline

  5. 4 Square Step Test

    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

    Measured: Mean change from follow up (study visit 4) and baseline

  6. EuroQol 5 Dimension Version 5-level (EQ-5D-5L)

    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.

    Measured: Mean change from follow up (study visit 4) and baseline

  7. Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool

    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

    Measured: Mean change from follow up (study visit 4) and baseline

  8. Number of Participants With Adverse Events

    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

    Measured: Study visit 1, 2, 3 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start24 Sep 2019
  3. Primary completion14 Mar 2020
  4. Study completion1 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04037436
Sponsor's protocol ID
20190401
Acronym
MoveStrong
Status last verified
Nov 2022
First submitted
28 Jun 2019
Last updated
22 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.

Publications

  • 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.

    PubMed 25810912
  • 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.

    PubMed 25241753
  • 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.

    PubMed 27707740
  • 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.

    PubMed 11253156
  • 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.

    PubMed 24866862
  • 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.

    PubMed 23036876
  • 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.

    PubMed 24281053
  • 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.

    PubMed 27486153
  • 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.

    PubMed 10474547
  • 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.

    PubMed 20543750
  • 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.

    PubMed 26420238
  • 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.

    PubMed 19588334
  • 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.

    PubMed 29310138
  • 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.

    PubMed 36108334
  • 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.

    PubMed 35766913

Questions about this trial

What is this clinical trial studying?

A study testing Strength and Balance Training & Nutrition Education in people with Chronic Disease and Frail, run by University of Waterloo at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment (time frame: 2 month (September to October 2019)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04037436, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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