- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335068
Effects of Exercise Snacking on Physical Fitness, Cognition, and Pain in Institutionalized Older Adults (EXSNAKS)
The Effects of Exercise Snacking on Physical Fitness, Cognitive Function, and Chronic Pain in Institutionalized Older Adults: A Randomized Controlled Trial
This study aims to compare the effects of two different exercise approaches on health and well-being in older adults living in residential care facilities. One approach, called "exercise snacking," consists of short and frequent bouts of physical activity spread throughout the day, while the other involves longer, structured exercise sessions performed a few times per week.
Approximately 75 adults aged 65 years and older will be randomly assigned to one of the two exercise programs and will participate for 12 weeks. The study will examine whether exercise snacking is as effective as conventional exercise in improving physical fitness, cognitive function, chronic pain intensity, quality of life, and symptoms of anxiety and depression.
The researchers hypothesize that short, intermittent exercise sessions may provide similar or greater health benefits compared to traditional exercise programs and may represent a practical and accessible strategy to promote physical activity in older adults living in institutional settings.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lisbon, Portugal, 1500-661
- Associação Casapiana de Solidariedade
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 65 years
- Residence in Associação Casapiana de Solidariedade
Exclusion Criteria:
- Severe cognitive impairment (MMSE 0-10)
- Unstable medical conditions (e.g., decompensated heart failure)
- Refusal of consent
- Total inability to walk/move.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Snacks
The Exercise Snacks intervention comprises two daily sessions of approximately ten minutes each, five days per week (total ≈ 100 minutes/week).
Each ten-minute session consists largely of alternating one-minute bouts of activity and one-minute rest.
The exercises followed a structured three-month progression.
Intensity targeted at a 4 on Borg CR10 Scale "somewhat hard" with progression rules (increase repetitions, range of motion and exercise difficulty).
|
Exercise snacks, defined as short bouts of gentle intermittent exercise performed twice a day
|
|
Active Comparator: Conventional Exercise
Conventional Exercise comprises two supervised 50 minutes sessions per week (total ≈ 100 minutes/week).
Organized in one-minute exercise/one-minute rest intervals equal in content to the snacks but performed in longer continuous practice.
The exercises followed a structured three-month progression.
Intensity targeted at a 4 on Borg CR10 Scale "somewhat hard" with progression rules (increase repetitions, range of motion and exercise difficulty).
|
Conventional exercise consists of longer continuous practice of structured physical activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Fitness Assessed by the Short Physical Performance Battery (SPPB)
Time Frame: Baseline and 3 months
|
The Short Physical Performance Battery (SPPB) is a test of lower extremity functioning that combines scores from usual gait speed, standing balance, and chair stand tests.
Scores range from 0 to 12, with higher scores indicating better physical functioning.
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nordic Musculoskeletal Questionnaire (NMQ)
Time Frame: From baseline to 3 months
|
Pain will be assessed using the Nordic Musculoskeletal Questionnaire.
Participants will report as yes/no the presence of chronic pain (pain that persists or recurs more than three months) in nine body regions (neck, shoulders, elbows, wrists/hands, upper back, lower back, hips/thighs, knees, and ankles/feet).
Symptom intensity in the last 7 days will be rated on a numeric scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
|
From baseline to 3 months
|
|
The 12-Item Short-Form Health Survey (SF-12)
Time Frame: From baseline to 3 months
|
The SF-12 includes 12 items covering eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).
Responses will be scored using standard algorithms to generate two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Scores will range from 0 to 100, with higher scores indicating better health-related quality of life.
Outcomes will be reported as mean PCS and MCS scores.
|
From baseline to 3 months
|
|
Mini-Mental State Examination (MMSE)
Time Frame: From baseline to 3 months
|
Cognitive function will be assessed using the MMSE, a standardized interviewer-administered screening tool.
The MMSE will evaluate orientation, attention, memory, language, and visuospatial abilities.
Total scores will range from 0 to 30, with higher scores indicating better cognitive function.
Cognitive impairment will be defined according to education-adjusted cut-off scores, as follows: illiterate participants ≤15 points; participants with 1 to 11 years of education ≤22 points; and participants with more than 11 years of education ≤27 points.
|
From baseline to 3 months
|
|
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) subscale scores
Time Frame: From baseline to 3 months
|
HADS consists of two subscales, one measuring anxiety, with seven items, and one measuring depression, with seven items, which are scored separately.
Each item was answered by the participant on a 4-point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression.
The HADS manual indicates that a score between 0 and 7 is ''normal'', between 8 and 10 ''mild'', between 11 and 14 ''moderate'' and between 15 and 21 ''severe''.
|
From baseline to 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1025B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
University Rovira i VirgiliMinisterio de Ciencia e Innovación, SpainNot yet recruitingChronic Post-operative Pain | Chronic Postsurgical Pain | Chronic Post-surgical Pain | Chronic Postoperative PainSpain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Bjorn AngKarolinska Institutet; The Swedish Research Council; Göteborg University; Forte; Dalarna...Not yet recruitingPain Management | Pain, Chronic | Chronic Pain, WidespreadSweden
-
University of FaisalabadNot yet recruiting
-
Universidade do Vale do ParaíbaCAPES Foundation - Ministry of Education, Brazil.Enrolling by invitationChronic Low Back Pain | Chronic Shoulder Pain | Chronic Knee PainBrazil
-
Washington D.C. Veterans Affairs Medical CenterRecruitingChronic Back Pain | Chronic Pain (back / Neck)United States
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Connecticut Children's Medical CenterRecruitingChronic Pain | Pain, Chronic | Chronic Pain SyndromeUnited States
-
The University of Texas Health Science Center,...RecruitingJoint Pain | Chronic Knee Pain | Chronic Pain (Back / Neck) | Chronic Pain ManagementUnited States
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
Clinical Trials on Exercise Snacks
-
Chimei Medical CenterNot yet recruitingPhysical Inactivity | Prediabetes / Type 2 Diabetes | Sedentary BehaviorsTaiwan
-
University of British ColumbiaMcMaster UniversityRecruiting
-
University of British ColumbiaMcMaster UniversityRecruiting
-
University of British ColumbiaMcMaster UniversityRecruiting
-
Jinan University GuangzhouCompletedAdolescent Behavior | Smartphone Addiction | Sedentary BehaviorsHong Kong
-
Seoul National UniversityNot yet recruitingMetabolic Syndrome | Prediabetes
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
Beijing Sport UniversityNot yet recruitingCardiorespiratory Fitness | Cardiovascular FunctionChina
-
King's College LondonTulā Code LtdRecruitingQuality of Life | Sleep | Mood | Perimenopause | Gut -Microbiota | Perimenopause-Related DepressionUnited Kingdom