Functional Exercise and Nutrition Education Program for Older Adults

Stroke Clinical Trial

— MoveStrong  

Official title:

A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037436
• Other study ID #: 20190401
• Status: Completed
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 1, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Bone Diseases, Metabolic
• Cancer
• Cardiovascular Diseases
• Chronic Disease
• Chronic Lung Disease
• Congestive Heart Failure
• Diabetes Mellitus
• Frail
• Heart Failure
• Hypertension
• Kidney Diseases
• Lung Diseases
• Osteoporosis
• Osteoporosis, Osteopenia
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Chaplin Family YMCA	Cambridge	Ontario
Canada	The Village of Arbour Trails	Guelph	Ontario
Canada	A.R. Kaufman Family YMCA	Kitchener	Ontario
Canada	Village of Winston Park	Kitchener	Ontario
Canada	Your Family Health Team	Sudbury	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
University of Waterloo	Canadian Institutes of Health Research (CIHR), City of Lakes family Health Team, Kinnect to Wellness, Schlegel Villages and Research Institute for Aging, YMCA

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Beaudart C, Rizzoli R, Bruyère 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. — View Citation

Borde R, Hortobágyi 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. Review. — View Citation

Brosseau L, Wells GA, Poitras S, Tugwell P, Casimiro L, Novikov M, Loew L, Sredic D, Clément S, Gravelle A, Kresic D, Hua K, Lakic A, Ménard G, Sabourin S, Bolduc MA, Ratté I, McEwan J, Furlan AD, Gross A, Dagenais S, Dryden T, Muckenheim R, Côté R, Paré — View Citation

Cruz-Jentoft AJ, Landi F, Schneider SM, Zúñiga 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 s — View Citation

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. — View Citation

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. Osteo — View Citation

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. Review. — View Citation

Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD002759. doi: 10.1002/14651858.CD002759.pub2. Review. — View Citation

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 o — View Citation

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. Review. — View Citation

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 — View Citation

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. do — View Citation

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 Randomi — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment	Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.	1 month (August 1 to 31st, 2019)
Primary	Feasibility - Retention	Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.	Start of the program to 9 weeks
Primary	Feasibility - Adherence	Definition: Percentage of individuals that attended exercise and nutrition sessions.; The criterion for success is 70% or higher.	18 weeks after the start of the program
Secondary	Body weight	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.	Start of the program and 18 weeks after the start
Secondary	10 Meter Walk Test	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.	Start of the program and every 6 weeks until the 18th week
Secondary	Center for Epidemiological Study Depression Scale	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)	Start of the program and every 6 weeks until the 18th week
Secondary	Physical Activity Scale	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.	Start of the program and every 6 weeks until the 18th week
Secondary	Grip Strength	Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer	Start of the program and every 6 weeks until the 18th week
Secondary	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. 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).	Start of the program and every 6 weeks until the 18th week
Secondary	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	Start of the program and every 6 weeks until the 18th week
Secondary	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 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	Start of the program and every 6 weeks until the 18th week
Secondary	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	Start of the program and every 6 weeks until the 18th week
Secondary	Participant and provider experience	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	18 weeks after the start of the program
Secondary	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	every 6 weeks until the 18th week after the start of the program
Secondary	Resource use	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	Start of the program and every 6 weeks until the 18th week
Secondary	Resource use	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	Start of the program and every 6 weeks until the 18th week