NCT04663685

Brief Summary

Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong was delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition Q\&A sessions and group discussion sessions over Microsoft® Teams. The primary aim of this study was to assess feasibility and acceptability of a remote model as determined by recruitment (≥ 25 people in 3 months), retention (≥80%), adherence of (70%) and participant experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 13, 2024

Completed
Last Updated

May 13, 2024

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

October 8, 2020

Results QC Date

May 4, 2022

Last Update Submit

November 30, 2023

Conditions

Keywords

remote deliveryexercisepre-frailnutritionpilot study

Outcome Measures

Primary Outcomes (4)

  • Recruitment

    The number of participants recruited \>25.

    Through study completion, an average of 12 weeks

  • Retention

    Feasibility threshold: The number of participants retained at follow-up \>80%.

    Through study completion, an average of 12 weeks

  • Average Adherence to Nutrition Sessions

    Participants were encouraged to attend 3 nutrition sessions that took place on weeks 2, 4 and 6 of the intervention (12 weeks). Feasibility threshold: "Attendance" or the average proportion of nutrition sessions \>67% or \>2/3 sessions.

    Through study completion, an average of 12 weeks

  • Average Adherence to Exercise Sessions

    Participants were encouraged to complete at least 3 exercise sessions per week (one supervised and two independent) for the duration of the intervention (12 weeks). Feasibility threshold: "Attendance" or the average proportion of exercise sessions completed \>70% or 25.3/36 sessions.

    Through study completion, an average of 12 weeks

Secondary Outcomes (9)

  • Physical Activity

    Baseline, week 9, week 12

  • Exercise Self-efficacy Scale

    Baseline, week 9, week 12

  • 30-second Chair Stand

    Baseline, week 9, week 12

  • Static Balance

    Baseline, week 9, week 12

  • Fatigue

    Baseline, week 9, week 12

  • +4 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL

This was the only arm in the study. All participants were allocated to this arm, where they received an 8-week remotely-delivered exercise and nutrition program.

Other: Exercise programOther: Nutrition education

Interventions

Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift \& carry and calf raise.

Single Arm

Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q\&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake.

Single Arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has at least one of the following chronic conditions: arthritis, cancer (other than minor skin cancer), cardiovascular disease, chronic lung disease, congestive heart failure, diabetes, hypertension, kidney disease, obesity, osteoporosis, stroke
  • Scored ≥ 1 point on the FRAIL Scale
  • Able to give informed consent

You may not qualify if:

  • Current or recent (within the past 6 months)participation in progressive resistance training program ≥ 2 times per week
  • Receiving palliative care
  • Unable to perform basic activities of daily living or follow 2-step commands (moderate-severe cognitive impairment)
  • Upcoming travel plans (travelling\> 1 week during the program)
  • Absolute exercise contraindications (ACSM guidelines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Canada

Location

Related Publications (14)

  • Greenwood JL, Joy EA, Stanford JB. The Physical Activity Vital Sign: a primary care tool to guide counseling for obesity. J Phys Act Health. 2010 Sep;7(5):571-6. doi: 10.1123/jpah.7.5.571.

    PMID: 20864751BACKGROUND
  • Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.

    PMID: 10882320BACKGROUND
  • McAuley E, Mailey EL, Mullen SP, Szabo AN, Wojcicki TR, White SM, Gothe N, Olson EA, Kramer AF. Growth trajectories of exercise self-efficacy in older adults: influence of measures and initial status. Health Psychol. 2011 Jan;30(1):75-83. doi: 10.1037/a0021567.

    PMID: 21038962BACKGROUND
  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PMID: 7624188BACKGROUND
  • Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

    PMID: 10380242BACKGROUND
  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PMID: 8126356BACKGROUND
  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND
  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PMID: 21479777BACKGROUND
  • Keller HH, Goy R, Kane SL. Validity and reliability of SCREEN II (Seniors in the community: risk evaluation for eating and nutrition, Version II). Eur J Clin Nutr. 2005 Oct;59(10):1149-57. doi: 10.1038/sj.ejcn.1602225.

    PMID: 16015256BACKGROUND
  • Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available.

    PMID: 22704899BACKGROUND
  • Clark RE, Milligan J, Ashe MC, Faulkner G, Canfield C, Funnell L, Brien S, Butt DA, Mehan U, Samson K, Papaioannou A, Giangregorio L. A patient-oriented approach to the development of a primary care physical activity screen for embedding into electronic medical records. Appl Physiol Nutr Metab. 2021 Jun;46(6):589-596. doi: 10.1139/apnm-2020-0356. Epub 2020 Nov 23.

    PMID: 33226847BACKGROUND
  • Radloff, LS. The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement,1977; 1(3), 385-401.

    BACKGROUND
  • Xie F, Pullenayegum E, Gaebel K, Bansback N, Bryan S, Ohinmaa A, Poissant L, Johnson JA; Canadian EQ-5D-5L Valuation Study Group. A Time Trade-off-derived Value Set of the EQ-5D-5L for Canada. Med Care. 2016 Jan;54(1):98-105. doi: 10.1097/MLR.0000000000000447.

    PMID: 26492214BACKGROUND
  • 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.

MeSH Terms

Conditions

ArthritisNeoplasmsCardiovascular DiseasesHeart FailureDiabetes MellitusHypertensionKidney DiseasesObesityOsteoporosisStrokeFrailtyMotor Activity

Interventions

Resistance TrainingNutrition Assessment

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesHeart DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, MetabolicBone DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Ellen Wang
Organization
UBC/Arthritis Research Canada

Study Officials

  • Lora Giangregorio, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is an 8-week feasibility study with a 4-week follow-up. Time series design. Note: 6-month follow-up was optional and exploratory in nature.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

December 11, 2020

Study Start

October 5, 2020

Primary Completion

April 9, 2021

Study Completion

October 12, 2021

Last Updated

May 13, 2024

Results First Posted

May 13, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations