COMPASS 65+ - Community-based Physical Activity Snacks for Healthy Aging in Overweight and Obese Aged Adults
NCT ID: NCT07289529
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2026-03-31
2026-09-30
Brief Summary
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This research project, called COMPASS 65+, will test an innovative approach called "snack exercise." Instead of one long workout, "snack exercise" involves doing several short bouts of activity, a few minutes at a time, throughout the day. The main idea is that these short, frequent bouts of activity might be easier to fit into a daily routine and less tiring than longer exercise sessions.
The purpose of this study is to see if a "snack exercise" program is a feasible and enjoyable way for adults aged 65 and over, who are overweight or obese, to improve their health. The study will be conducted in two main parts. First, the research team will talk with older adults to understand what helps or hinders them from being active to co-design the program. Second, volunteers will be randomly assigned to either a "snack exercise" group or a control group.
Participants in the "snack exercise" group will attend sessions that combine theory and practice to learn how to perform these exercises and will receive individualized prescriptions to perform the "snacks" (short bouts) at home. The control group will receive a brief educational counselling session on physical activity. Participants' health status, body composition, and physical fitness will be assessed at baseline, after the 12 weeks intervention, and again 6 weeks post-intervention to evaluate the maintenance of any improvements. These outcomes will help determine whether short bouts of 'exercise snacking' constitute a feasible and effective strategy to promote functional capacity, metabolic health, and long-term adherence to physical activity.
Detailed Description
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This study, COMPASS 65+, proposes to evaluate an innovative exercise modality known as "snack exercise." This approach involves short, frequent bouts of physical activity performed throughout the day, designed to be more accessible and less burdensome than conventional exercise routines. The primary aim of this project is to assess the feasibility, acceptability, and preliminary effects of a community-based "snack exercise" program, co-designed with input from the target population, for overweight and obese older adults. The findings are intended to provide the necessary evidence to design a future, definitive large-scale randomized controlled trial (RCT).
Study Design
The research plan is structured in two sequential phases:
1. Phase 1: Exploratory Mixed-Methods Study This initial phase is designed to inform the development of the intervention. It involves a mixed-methods approach to identify barriers, facilitators, and preferences related to physical activity among the target population.
* Quantitative Component: A cross-sectional survey will be administered to a convenience sample of 370 adults aged 65 or older with a Body Mass Index (BMI) of 25 kg/m² or greater. The survey will include validated instruments such as the Exercise Benefits/Barriers Scale (EBBS) and the Multimorbidity Treatment Burden Questionnaire (MTBQ).
* Qualitative Component: Focus groups will be conducted with a randomly selected subset of the target population to explore user preferences for program design.The data will be integrated to co-design a "snack exercise" intervention that is evidence-based and tailored to user needs.
2. Phase 2: Feasibility Randomized Controlled Trial (RCT) A two-arm, parallel-group feasibility RCT will be conducted to test the co-designed intervention.
* Participants: A target of 60 participants will be recruited from primary care settings. Inclusion criteria include adults aged ≥ 65 years with a BMI ≥ 25 kg/m². Exclusion criteria include significant cognitive deficits, contraindications to exercise (assessed via PAR-Q+), major cardiovascular events within the last 3 months, unstable chronic disease, or severe mobility impairment.
* Randomization: Participants will be randomly allocated (1:1) to either the intervention group or the control group.
* Timeline: The intervention lasts 12 weeks, followed by a 6-week post-intervention "washout" period. Assessments occur at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).
* Intervention Groups Active Comparator (Control Group): Participants will receive a single, standardized Brief Educational Counselling Session (60 minutes) at baseline (T0). Delivered by trained research personnel, this session provides foundational information on the benefits of physical activity for healthy aging and offers practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline.
Experimental Group ("Snack Exercise"): Participants will receive the standardized Brief Educational Counselling Session at baseline, followed by the Structured Community-based Physical Activity Snack Intervention. This program consists of group-based, theoretico-practical sessions held 2-3 times per week, each lasting approximately 45 minutes. Sessions are guided by a physical exercise professional and focus on explaining and practicing the prescribed snack exercises. Crucially, at the end of each session, participants are provided with an individualized physical prescription to perform at home. Exercise intensity is monitored using perceived exertion scales (BORG-OMNI), progressing from light to moderate intensity per WHO recommendations.
Study Procedures and Outcome Measures Protocol \& Ethics: The study adheres to SPIRIT guidelines and the Declaration of Helsinki, with Ethics Committee approval and written informed consent required.
Outcomes \& Data Collection: Comprehensive assessments are conducted at T0, T1, and T2 using validated instruments and objective tools:
* Body Composition \& Anthropometrics: Dual-Energy X-ray Absorptiometry (DEXA) for fat/lean mass and bone density; Height, Weight, BMI (kg/m\^2), and Waist Circumference.
* Cardiorespiratory Fitness: One-Mile Walk Test to predict aerobic capacity (VO2 max).
* Functional Fitness \& Fall Risk: The Short Physical Performance Battery (SPPB) (assessing balance, gait speed, and chair stands) and the 30-second Chair Stand Test (muscular endurance).
* Stability: Limits of stability assessed via a force platform (Physiosensing®).
* Daily Physical Activity: Objectively measured using a Fitband worn for five consecutive days (step count, active minutes).
* Psychosocial \& Health Status: Exercise Self-Efficacy Scale (ESES).
* Multidimensional Lifestyle and Health Status (assessed via the Healthy Lifestyle Assessment Toolkit, covering cardiometabolic health, well-being, nutrition, mental health, and sleep).
Statistical Analysis Plan Primary Analysis (Feasibility): Descriptive analysis of recruitment, adherence, retention, and protocol fidelity based on the RE-AIM framework.
Secondary Analysis (Preliminary Effects): Repeated measures ANOVA or mixed models will be used to assess changes over time (T0, T1, T2) and between groups (p\< 0.05). The goal is to estimate effect sizes to power a future definitive trial.
Data Management: All analyses will be conducted using SPSS (Version 29), with appropriate handling of missing data (e.g., multiple imputation).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brief educational counselling session
Participants will receive a brief educational counselling session (60 minutes) at the baseline assessment. This session will be a standardized brief educational counseling session delivered by trained research personnel during the baseline assessment. This session will provide foundational information on the benefits of physical activity for healthy aging and offer practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline for both study arms.
Brief educational counseling session
A standardized brief educational counseling session delivered by trained research personnel during the baseline assessment. This session will provide foundational information on the benefits of physical activity for healthy aging and offer practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline for both study arms.
Brief educational counselling session + Group-based "Snack Exercise" training and prescription
Participants will receive a standardized Brief Educational Counselling Session at baseline. This group will then proceed with the Structured Community-based Physical Activity Snack Intervention (COMPASS 65+). The program will consist of group-based, theory-based and practical sessions (held 2-3 times per week, each lasting approximately 45 minutes).
Group-based "Snack Exercise" Training and Prescription
This programme consists of supervised, group-based sessions (2-3 per week, \~45 minutes each) combining concise theoretical instruction with guided practical execution of the snack-exercise protocol. Sessions are delivered by a qualified exercise professional and focus on teaching correct technique, safety, and progression of the prescribed short exercise bouts ("exercise snacks").
At the end of each session, participants receive an individualized home-based exercise prescription, tailored to their functional capacity and progression markers. Exercise intensity during supervised and home practice is monitored using the OMNI-BORG perceived exertion scale, progressing from light to moderate intensity, in accordance with World Health Organization recommendations.
Brief educational counseling session
A standardized brief educational counseling session delivered by trained research personnel during the baseline assessment. This session will provide foundational information on the benefits of physical activity for healthy aging and offer practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline for both study arms.
Interventions
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Group-based "Snack Exercise" Training and Prescription
This programme consists of supervised, group-based sessions (2-3 per week, \~45 minutes each) combining concise theoretical instruction with guided practical execution of the snack-exercise protocol. Sessions are delivered by a qualified exercise professional and focus on teaching correct technique, safety, and progression of the prescribed short exercise bouts ("exercise snacks").
At the end of each session, participants receive an individualized home-based exercise prescription, tailored to their functional capacity and progression markers. Exercise intensity during supervised and home practice is monitored using the OMNI-BORG perceived exertion scale, progressing from light to moderate intensity, in accordance with World Health Organization recommendations.
Brief educational counseling session
A standardized brief educational counseling session delivered by trained research personnel during the baseline assessment. This session will provide foundational information on the benefits of physical activity for healthy aging and offer practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline for both study arms.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* contraindications to exercise (assessed via PAR-Q+),
* major cardiovascular events within the last 3 months,
* unstable chronic disease,
* severe mobility impairment.
65 Years
ALL
No
Sponsors
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University of Coimbra
OTHER
Responsible Party
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Susana Miguel
MSc, MD, PhD candidate
Principal Investigators
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Carlos S Cardoso, PhD, MD
Role: STUDY_DIRECTOR
University of Coimbra
Anabela M Pinto, PhD, MD
Role: STUDY_CHAIR
University of Coimbra
Susana P Miguel, MSc, MD
Role: PRINCIPAL_INVESTIGATOR
University of Coimbra
Guilherme Eustáquio Furtado, PhD
Role: STUDY_CHAIR
Polytechnic Institute of Coimbra
Locations
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Fernão de Magalhães Health Center
Coimbra, , Portugal
Countries
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Central Contacts
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References
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Reis F, Sa-Moura B, Guardado D, Couceiro P, Catarino L, Mota-Pinto A, Verissimo MT, Teixeira AM, Ferreira PL, Lima MP, Palavra F, Rama L, Santos L, van der Heijden RA, Goncalves CE, Cunha A, Malva JO. Development of a Healthy Lifestyle Assessment Toolkit for the General Public. Front Med (Lausanne). 2019 Jun 27;6:134. doi: 10.3389/fmed.2019.00134. eCollection 2019.
Vancea A, Iliescu M, Aivaz KA, Popescu MN, Beiu C, Spiru L. Improving Functional Capacities and Well-Being in Older Adults: Strategies in Physical Medicine and Rehabilitation. Cureus. 2024 Aug 6;16(8):e66254. doi: 10.7759/cureus.66254. eCollection 2024 Aug.
Rodrigues RN, Carballeira E, Silva F, Caldo-Silva A, Abreu C, Furtado GE, Teixeira AM. The Effect of a Resistance Training, Detraining and Retraining Cycle on Postural Stability and Estimated Fall Risk in Institutionalized Older Persons: A 40-Week Intervention. Healthcare (Basel). 2022 Apr 22;10(5):776. doi: 10.3390/healthcare10050776.
Nuzzo JL, Pinto MD, Kirk BJC, Nosaka K. Resistance Exercise Minimal Dose Strategies for Increasing Muscle Strength in the General Population: an Overview. Sports Med. 2024 May;54(5):1139-1162. doi: 10.1007/s40279-024-02009-0. Epub 2024 Mar 20.
Lee PG, Jackson EA, Richardson CR. Exercise Prescriptions in Older Adults. Am Fam Physician. 2017 Apr 1;95(7):425-432.
Hashimoto K, Dora K, Murakami Y, Matsumura T, Yuuki IW, Yang S, Hashimoto T. Positive impact of a 10-min walk immediately after glucose intake on postprandial glucose levels. Sci Rep. 2025 Jul 2;15(1):22662. doi: 10.1038/s41598-025-07312-y.
Evans K, Abdelhafiz D, Abdelhafiz AH. Sarcopenic obesity as a determinant of cardiovascular disease risk in older people: a systematic review. Postgrad Med. 2021 Nov;133(8):831-842. doi: 10.1080/00325481.2021.1942934. Epub 2021 Jul 12.
Eitmann S, Matrai P, Hegyi P, Balasko M, Eross B, Dorogi K, Petervari E. Obesity paradox in older sarcopenic adults - a delay in aging: A systematic review and meta-analysis. Ageing Res Rev. 2024 Jan;93:102164. doi: 10.1016/j.arr.2023.102164. Epub 2023 Dec 14.
Collado-Mateo D, Lavin-Perez AM, Penacoba C, Del Coso J, Leyton-Roman M, Luque-Casado A, Gasque P, Fernandez-Del-Olmo MA, Amado-Alonso D. Key Factors Associated with Adherence to Physical Exercise in Patients with Chronic Diseases and Older Adults: An Umbrella Review. Int J Environ Res Public Health. 2021 Feb 19;18(4):2023. doi: 10.3390/ijerph18042023.
Campisi J, Kapahi P, Lithgow GJ, Melov S, Newman JC, Verdin E. From discoveries in ageing research to therapeutics for healthy ageing. Nature. 2019 Jul;571(7764):183-192. doi: 10.1038/s41586-019-1365-2. Epub 2019 Jul 10.
Other Identifiers
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2025.08868.SAU+
Identifier Type: -
Identifier Source: org_study_id