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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|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)|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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
- 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).
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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
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|Cambridge, Ontario, Canada|
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|Your Family Health Team|
|Sudbury, Ontario, Canada, P3A 2T4|