Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Exercise and Nutrition Education Program for Older Adults (MoveStrong)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037436
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
City of Lakes family Health Team
Schlegel Villages and Research Institute for Aging
YMCA
Kinnect to Wellness
Information provided by (Responsible Party):
University of Waterloo

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Frail Diabetes Mellitus Cancer Chronic Lung Disease Cardiovascular Diseases Congestive Heart Failure Hypertension Osteoporosis, Osteopenia Arthritis Stroke Kidney Diseases Other: Strength and Balance Training & Nutrition Education Other: Usual Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial
Actual Study Start Date : September 24, 2019
Actual Primary Completion Date : March 14, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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.
Other: Strength and Balance Training & Nutrition Education
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.

Control
Each cluster contributes observations under both control and intervention observation periods.
Other: Usual Care
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 Outcome Measures :
  1. Feasibility - Recruitment [ Time Frame: 1 month (August 1 to 31st, 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: 18 weeks after the start of the program ]

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

    The criterion for success is 70% or higher.



Secondary Outcome Measures :
  1. Body weight [ Time Frame: Start of the program and 18 weeks after the start ]
    Fried Frailty Index Components: We will measure the change in body weight with a calibrated scale. A change of 5% (greater or lower) in 1 year is considered worse.

  2. 10 Meter Walk Test [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. A change of 0.05 m/s is considered as a small meaningful change, while 0.13m/s is considered a substantial change.

  3. Center for Epidemiological Study Depression Scale [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    Fried Frailty Index Components: fatigue/exhaustion via the Center for Epidemiologic Study Depression Scale-Fatigue Questions. The score ranges from 0-60 (higher scores reflect increased symptom severity)

  4. Physical Activity Scale [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    Fried Frailty Index Components: lower physical activity via the CHAMPS Physical Activity Questionnaire for older adults. No score, but the recommended physical activity levels are 150 minutes of moderate to vigorous activity and 2 days of strength training of major muscle groups.

  5. Grip Strength [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer

  6. 30 Second Chair Stand Test [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    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. Scores range depending on age and sex (e.g., male 60 to 64, < 14 chair stands is considered below average, while a male 65 to 69, < 12 is below average).

  7. 4 Square Step Test [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    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

  8. EuroQol 5 dimension version 5-level (EQ-5D-5L) [ Time Frame: Start of the program and every 6 weeks until the 18th week ]

    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 EuroQol 5 dimension version 5-level (EQ-5D-5L) also records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). This information can be used as a quantitative measure of health as judged by the individual respondents. A higher score indicates better quality of life


  9. Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    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

  10. Participant and provider experience [ Time Frame: 18 weeks after the start of the program ]
    We will use 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

  11. Adverse events [ Time Frame: every 6 weeks until the 18th week after the start of the program ]
    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

  12. Resource use [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    We will use the Productivity and Activity Index questionnaire to assess indirect resource use over the last 6 weeks of the program.There is no scale to this section

  13. Resource use [ Time Frame: Start of the program and every 6 weeks until the 18th week ]
    We will use the Health Utility Form to assess direct medical resource use over the last 6 weeks of the program. Direct medical costs will be measured using a closed and open-ended survey about their personnel, hospitalization, medications, rehabilitation, and test costs. This questionnaire also evaluates out of pocket expenses and transportation.There is no scale to this section



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037436


Locations
Layout table for location information
Canada, Ontario
Chaplin Family YMCA
Cambridge, Ontario, Canada
The Village of Arbour Trails
Guelph, Ontario, Canada, N1G 0C9
Village of Winston Park
Kitchener, Ontario, Canada, N2E 3K1
A.R. Kaufman Family YMCA
Kitchener, Ontario, Canada, N2G 3C5
Your Family Health Team
Sudbury, Ontario, Canada, P3A 2T4
Sponsors and Collaborators
University of Waterloo
Canadian Institutes of Health Research (CIHR)
City of Lakes family Health Team
Schlegel Villages and Research Institute for Aging
YMCA
Kinnect to Wellness
  Study Documents (Full-Text)

Documents provided by University of Waterloo:
Publications of Results:

Layout table for additonal information
Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT04037436    
Other Study ID Numbers: 20190401
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Waterloo:
Strength Training
Balance Training
Nutrition Education
Older adults
Frailty
Feasibility
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Lung Diseases
Kidney Diseases
Heart Failure
Cardiovascular Diseases
Chronic Disease
Heart Diseases
Musculoskeletal Diseases
Urologic Diseases
Bone Diseases
Metabolic Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes