Healthy People ProgramsPilates&STNCT07119762

Effects of 20-week Mat-Pilates & Dual-Task Training on Strength, Balance, Cognition, and Fall Risk in Older Adults

A study testing Pilates sections in people with Healthy People Programs, run by Universidade do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy People Programs
What is being tested?: Pilates sections
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 sitePortugal
Study dates: 1 Jun 2025to 30 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Older adults (≥ 60 years)
Both sexes
Healthy (no diseases or diagnoses that prevent physical exercise)
Community-dwelling

Who cannot join

Individuals diagnosed with medical conditions for which physical activity is not recommended, including, but not limited to, musculoskeletal problems, cardiovascular diseases, and/or severe respiratory diseases.
Participants with neurological diseases or disabling conditions that compromise balance.
Individuals with moderate or severe cognitive impairment, according to established normative test values.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

CIAFEL
Porto, Porto District

Other trials in Portugal

About this study

Official title: Effects of a 20-week Combined Mat-Pilates Training With Dual Task Exercise for Improving Trunk Strength and Stability, Balance, Cognitive Function, and Risk of Falls in Older Adults.

Our aims are to evaluate the impact of 20-week combined Pilates and dual-task exercises on physical fitness, balance, cognitive function, bone density in older adults. Participants ≥ 65 years of both genders will be randomly allocated to a control (n= 55) or intervention group (n= 55). Twice a week, sessions will take place in the FADEUP- UPORTO, with moderate intensity Pilates exercise and dual-task exercises. Trunk strength and stability, balance, cognitive function, and physical fitness will be accessed before and after the intervention. The Pilates method is easy to apply, low cost and widely accepted by older adults and it can integrate dual-task exercises easily. The researcher expected the intervention to improve balance, physical and cognitive skills of the participants, which may reduce the number of falls. The investigators seek to contribute with relevant information and enlighten the Dual Task-Pilates program as a safe strategy to reduce falls and maintain elderly's autonomy.

Read the detailed description

To accomplish our aims the following tasks will be conducted:

Disclosure, recruitment and participants characterization (3 months). Participants of both genders, ≥ 65 years old, living in the community, with independent mobility, will be recruited through the "Mais Ativos Mais Vividos" project (in FADEUP), senior universities, and healthcare centers. This is a longitudinal experimental study. For sample size, an a priori calculation of statistical power (G*Power 3.1, Dusseldorf, Germany) was performed based on an Ancova. The sample size required to detect an effect size of 0.40; α err prob 0.05 and a power of 0.80 is 111 subjects to accommodate a maximum dropout rate of 20%.
Participant´ Assessments (2 months) Participants will be submitted to the following measurements at 2 time points, baseline and post-intervention. I - Sociodemographic data and clinical characterization, collected by questionnaire; and health status with Short Form Health Survey (SF-36) II - Weight and height will be measured with a SECA 899 scale and SECA 217 stadiometer (Hamburg, Germany); III - Body composition and bone mineral density will be determined by DEXA, Hologic Explorer QDR 4500 (Bedford, MA / USA); IV - Habitual physical activity assessed by Link ActiGraph GT9X accelerometers for 7 consecutive days (confounder); V - Functional evaluation by the senior fitness test (SFT) including lower (chair stand) and upper (arm curl) limb strength, lower (sit reach) and upper (back scratch) limb flexibility, agility and dynamic balance (timed up and go) and cardiorespiratory endurance (walk 6 min); VI- Handgrip strength with the Jamar analog dynamometer; VII- Balance assessment made in Biodex Balance System SD platform (Biodex Medical Systems, Shirley, NY), including Sensory Integration (CTSIB) and Falls Risk; VIII- Trunk strength assessed using the Biodex System 4 Pro isokinetic dynamometer (Medical Systems, Shirley, NY, USA); IX- Stability of the trunk muscles with Stabilizer Pressure Biofeedback; X- Assessment of cognitive function using the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Stroop Color and Word Test (SCWT), Wechsler Adult Intelligence Scale (WAIS III) e Wechsler Memory Scale (WMS), conducted by an experienced psychologist; XI-Assessment of the cost of dual tasking using the Cognitive timed up ang go.
Intervention (5 months) Participants will be allocated to the Experimental Group (EG) and Control Group (CG) in a 1:1 ratio. In the EG, participants will be divided into small groups of 15 to 18 individuals. The exercise program, conducted at FADEUP, will run for 20 weeks, consisting of two 60-minute sessions per week at moderate to vigorous intensity. Heart rate monitors (GARMIN Vivosmart 4) and the Borg Rating of Perceived Exertion Scale (1 to 10) will be used to monitor intensity. The program will begin with a 3-week period at light intensity (57% to 63% of maximum heart rate), followed by a progression to moderate intensity (64% to 76%) from weeks 4 to 10, and to moderate-to-vigorous intensity (77% to 95%) from week 11 onward, with increasing complexity of exercises. The methodology is based on international training approaches from Polestar® and PhysicalMind® schools. The program includes Pilates exercises designed to improve trunk strength and stability (core), spinal mobility, upper and lower limb strength and flexibility, coordination, balance, agility, control, and concentration. The method emphasizes slow and controlled movements, focusing on both concentric and eccentric phases, with correct posture and movement quality. Dual-task exercises will be integrated into the Pilates routine, combining cognitive activities with physical tasks to promote attention and concentration. The selected Pilates exercises include: Cat, Swan, Mermaid, Spine Twist, Spine Stretch Forward, Squat, One Leg Circle, The Roll Down, The Roll Up, The Hundred, Single Leg Stretch, Double Leg Stretch, Bridge, Side Kick, Scissors, Bicycle, Scapular Support, Leg Pull Front, Leg Extension, Swimming, One Leg Kick, and Double Leg Kick. These exercises will be adapted for older adults using chairs, elastic bands, foam rollers, sticks, and balls to increase intensity and complexity.
Data analysis and processing Data will be entered into a database using SPSS (Statistical Package for the Social Sciences, version 29) and subsequently processed and analyzed. Descriptive statistics will be presented as medians and interquartile ranges or means and standard deviations, as well as counts and percentages, as appropriate. ANCOVA and repeated measures ANOVA will be used to compare differences between groups and time points. A 95% confidence interval will be applied. Only data from participants with an attendance rate of 75% or higher will be included in the analysis.
Dissemination of results This intervention is part of a doctoral project and will adhere to the principles of the Declaration of Helsink and the National Legislation. The results will be disseminated through four scientific articles and presentations at national and international conferences related to the study themes: physical and cognitive activity in older adults, Pilates, and fall risk.

Conditions: Healthy People Programs
Being tested: Pilates sections
Keywords: AGING., PHYSICAL EXERCISE, CORE STRENGTH, STABILITY
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pilates sectionsOther
This intervention combines Pilates with dual-task training over 20 weeks, featuring twice-weekly 60-minute sessions at moderate to vigorous intensity. It is uniquely grounded in methods from the Polestar and PhysicalMind schools and adapted for older adults (≥65 years), utilizing chairs, elastic bands, and minimal equipment. Unlike typical exercise programs, this protocol integrates cognitive tasks within Pilates exercises to simultaneously challenge physical and executive functions. Exercise intensity is individualized using heart rate monitors and the Borg scale. Assessments include trunk strength (Biodex System 4), balance (Biodex SD), and cognitive function (MoCA, Stroop, WAIS-III, TMT), making it one of the few trials to rigorously evaluate physical, cognitive, and dual-task performance outcomes in older adults. This approach is low-cost, scalable, and focused on fall prevention and autonomy maintenance.

Study groups in NCT07119762
Study group	Role	What they receive
Pilates	Experimental	depois Receives: Other: Pilates sections
Control Group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Balance- Biodex balance System SD
The Biodex Balance System SD plataform was used to assess balance through the Sensory Integration Test (CTSIB) and the Falls Risk Test. These assessments evaluate how the central nervous system processes sensory inputs (visual, and proprioceptive systems) to maintain postural control, helping to identify balance impairments and fall risk (Biodex Medical Systems, Shirley, NY).
Measured: Baseline, post 20 weeks.
Stability of the trunk muscles- Stabilzer Pressure Biofeedback Unit
The study by Grooms et al. (2013) evaluated trunk muscle stability using the Stabilizer Pressure Biofeedback Unit, a device that measures the activation of deep abdominal muscles during exercises. It helps ensure proper engagement of core stabilizers, such as the transversus abdominis and multifidus, making it useful for both assessment and rehabilitation.
Measured: Baseline, post 20 weeks
Balance- Single-Leg Stance Test
The Single-Leg Stance Test is a simple and widely used method for assessing static postural balance. It involves standing on one leg, with eyes open, for up to 45 seconds. This test has been validated by Springer et al. (2007), who demonstrated its reliability in detecting balance deficits and fall risk, particularly in older adults and clinical populations.
Measured: Baseline, post 20 weeks.
Functional Fitness (Strength)- SFT
The Senior Fitness Test includes specific assessments for upper and lower body strength in older adults. Lower body strength is measured using the 30-second chair stand test, which evaluates leg strength and endurance. Upper body strength is assessed with the 30-second arm curl test, measuring arm muscle strength. These tests were validated by Rikli and Jones (1999) and are considered reliable indicators of functional fitness in elderly populations.
Measured: Baseline; 20 weeks (post-intervention); 36 weeks (after 16-week detraining); 56 weeks (after second 20-week intervention in a subgroup)
Functional Fitness (Flexibility)- SFT
The Senior Fitness Test includes two flexibility assessments aimed at older adults: the Sit and Reach Test, which evaluates lower body flexibility, particularly of the hamstrings and lower back; and the Back Scratch Test, which assesses upper body flexibility, focusing on shoulder mobility. Both tests were validated by Rikli and Jones (1999) and are widely used to detect limitations in functional range of motion.
Measured: Beseline, post 20 weeks.
Cardiorespiratory endurance- SFT
The 6-Minute Walk Test is part of the Senior Fitness Test and evaluates cardiorespiratory endurance in older adults. Participants are instructed to walk as far as possible in six minutes along a 50-meter rectangular course. This test was validated by Rikli and Jones (1999) and is considered an excellent indicator of functional capacity for daily activities, such as climbing stairs or performing household tasks.
Measured: Baseline, post 20 weeks.
Dynamic balance and agility- 8-Foot Up-and-Go Test
The 8-Foot Up-and-Go Test is part of the Senior Fitness Test and assesses agility and dynamic balance in older adults. The participant must stand up from a chair, walk 2.44 meters (8 feet) quickly, turn around a cone, and return to the seat as fast as possible (Rikli and Jones, 1999).
Measured: Baseline, post 20 weeks.
Handgrip strength
Handgrip strength was assessed using the Jamar analog dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA), a gold-standard instrument widely used to measure upper limb strength. The test is simple, quick, and provides a reliable indicator of overall functional strength. The Jamar dynamometer has well-established validity in clinical research.
Measured: Baseline, 20 weeks.
Trunk strength- Biodex System 4 Pro isokinetic dynamometer
Trunk strength was assessed using the Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA), a highly accurate device used to measure muscular torque and power at various speeds. It is widely used in clinical and research settings to analyze muscular performance in a standardized and safe manner.
Measured: Baseline; 20 weeks (post-intervention); 36 weeks (after 16-week detraining); 56 weeks (after second 20-week intervention in a subgroup)

Secondary outcomes (9)

Cognitive function- MoCA
Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), a brief and validated tool for screening mild cognitive impairment. The test evaluates multiple cognitive domains, including memory, attention, language, visuospatial abilities, and executive function. The MoCA is sensitive for detecting early cognitive decline in older adults (Nasreddine, Z. S., et al., 2005).
Measured: Baseline, 20 weeks.
Cognitive function- Trail Making Test
Executive cognitive function was assessed using the Trail Making Test (TMT), parts A and B. Part A evaluates visual attention and processing speed, while part B measures cognitive flexibility and executive control, requiring alternating between numbers and letters. The TMT is widely used and validated for detecting cognitive impairment in older adults (Reitan, R. M., 1958).
Measured: Baseline, 20 weeks.
Cognitive function- Stroop Color and Word Test
The Stroop Color and Word Test (SCWT) was employed to assess cognitive inhibition and selective attention. The test includes reading color words, naming ink colors, and naming ink colors when the word and ink are incongruent. This version follows Bickford et al. (2018) and is sensitive to detecting cognitive interference, making it valuable in clinical settings to identify executive dysfunction.
Measured: Baseline, 20 weeks.
General intelligence- Wechsler Adult Intelligence Scale (WAIS-III)
General intelligence was assessed using the WAIS-III, a standardized scale that measures various cognitive domains in adults, including verbal comprehension, perceptual reasoning, working memory, and processing speed. It is widely recognized for its validity and reliability in the assessment of intellectual functioning (Wechsler, D., 1997).
Measured: Baseline, 20 weeks
Cognitive function- Memory function
Memory function was assessed using the Wechsler Memory Scale (WMS), a validated tool that evaluates immediate and delayed memory, attention, and learning ability. It is commonly used in clinical settings to diagnose memory disorders and monitor cognitive changes over time (Wechsler, D., 1997).
Measured: Baseline, 20 weeks.
Sociodemographic questionnaire and and clinical characterization
Sociodemographic questionnaire which includes the following variables: ID, group allocation, birth date, age, sex, education level, profession, number of falls, diagnosed diseases. Quality of life satisfaction will also be evaluated using self-report.
Measured: Baseline, 20 weeks.
Height assessment
Height was measured using the Seca 217 mobile stadiometer, with participants standing upright and barefoot. Measurements were recorded in centimeters.
Measured: Baseline, 20 weeks
Body mass
Body mass (kg), fat-free mass (kg), fat mass (kg) and BMI will be analyzed with bioimpedance (InBody 120®).
Measured: Baseline, 20 weeks.
Bone mineral density
Bone mineral density will be assessed by DEXA (Hologic QDR Explorer 4500, Bedford, MA, USA) at the lumbar spine and femoral neck.
Measured: Baseline; 20 weeks (post-intervention); 36 weeks (after 16-week detraining); 56 weeks (after second 20-week intervention in a subgroup)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202530 Jul 2026

First posted13 Aug 2025
Study start1 Jun 2025
Primary completion31 Oct 2025
Study completion30 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Healthy People ProgramsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Physical activity intervention (Pilates)
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07119762
Sponsor's protocol ID: CEFADE 41_2022
Other IDs: 2023.02364.BD, 2023
Acronym: Pilates&ST
Status last verified: Oct 2026
First submitted: 5 Aug 2025
Last updated: 27 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data management will comply with applicable data protection legislation and the internal guidelines of the University of Porto. All project-specific documents, including collected data, will be stored with full privacy and confidentiality, with access restricted to the principal investigator and their advisors. The data will be destroyed after the objectives of the study are fulfilled or after five years, whichever comes first. All information obtained through questionnaires and direct observation will be anonymized before storage.

Publications

García-Vaquero, M. P., García-Manso, J. M., Pérez-López, J., Olcina, G., & Molinero, O. (2016). Reliability and learning effects of an isokinetic trunk extension-flexion protocol using the Biodex System 4. Clinical Biomechanics, 31, 627-630. https://doi.org/10.1016/j.clinbiomech.2016.05.003
Reitan, R. M. (1958). Validity of the Trail Making Test as an Indicator of Organic Brain Damage. Perceptual and Motor Skills, 8(3), 271-276. https://doi.org/10.2466/pms.1958.8.3.271 (Original work published 1958)
Stroop, J. R. (1935). Studies of interference in serial verbal reactions. Journal of Experimental Psychology, 18(6), 643-662. https://doi.org/10.1037/h0054651
Intertester and intratester reliability of a dynamic balance protocol using the Biodex Stability System. Journal of Sport Rehabilitation, 7(2), 95-101. https://doi.org/10.1123/jsr.7.2.95
Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.
PubMed 19839175
Wechsler, D. (1997). WAIS-III: Wechsler Adult Intelligence Scale - Third Edition Manual. San Antonio, TX: The Psychological Corporation.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
Serious Mental Illness, Older Adults
Recruiting
Healthy Aging in People With Epilepsy Program
Epilepsy
Not yet recruiting
Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis
Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis
Recruiting
Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
Ageing

All Healthy People Programs trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a 20-week Combined Mat-Pilates Training With Dual Task Exercise for Improving Trunk Strength and Stability, Balance, Cognitive Function, and Risk of Falls in Older Adults.
ClinicalTrials.gov ID: NCT07119762
Acronym / sponsor ID: Pilates&ST / CEFADE 41_2022
Conditions: Healthy People Programs
Keywords: AGING., PHYSICAL EXERCISE, CORE STRENGTH, STABILITY
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Universidade do PortoUniversity, hospital or other
Study start: 1 Jun 2025 (actual)
Primary completion: 31 Oct 2025 (actual)
Study completion: 30 Jul 2026 (actual)
First posted: 13 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To accomplish our aims the following tasks will be conducted:

Disclosure, recruitment and participants characterization (3 months). Participants of both genders, ≥ 65 years old, living in the community, with independent mobility, will be recruited through the "Mais Ativos Mais Vividos" project (in FADEUP), senior universities, and healthcare centers. This is a longitudinal experimental study. For sample size, an a priori calculation of statistical power (G*Power 3.1, Dusseldorf, Germany) was performed based on an Ancova. The sample size required to detect an effect size of 0.40; α err prob 0.05 and a power of 0.80 is 111 subjects to accommodate a maximum dropout rate of 20%.
Participant´ Assessments (2 months) Participants will be submitted to the following measurements at 2 time points, baseline and post-intervention. I - Sociodemographic data and clinical characterization, collected by questionnaire; and health status with Short Form Health Survey (SF-36) II - Weight and height will be measured with a SECA 899 scale and SECA 217 stadiometer (Hamburg, Germany); III - Body composition and bone mineral density will be determined by DEXA, Hologic Explorer QDR 4500 (Bedford, MA / USA); IV - Habitual physical activity assessed by Link ActiGraph GT9X accelerometers for 7 consecutive days (confounder); V - Functional evaluation by the senior fitness test (SFT) including lower (chair stand) and upper (arm curl) limb strength, lower (sit reach) and upper (back scratch) limb flexibility, agility and dynamic balance (timed up and go) and cardiorespiratory endurance (walk 6 min); VI- Handgrip strength with the Jamar analog dynamometer; VII- Balance assessment made in Biodex Balance System SD platform (Biodex Medical Systems, Shirley, NY), including Sensory Integration (CTSIB) and Falls Risk; VIII- Trunk strength assessed using the Biodex System 4 Pro isokinetic dynamometer (Medical Systems, Shirley, NY, USA); IX- Stability of the trunk muscles with Stabilizer Pressure Biofeedback; X- Assessment of cognitive function using the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Stroop Color and Word Test (SCWT), Wechsler Adult Intelligence Scale (WAIS III) e Wechsler Memory Scale (WMS), conducted by an experienced psychologist; XI-Assessment of the cost of dual tasking using the Cognitive timed up ang go.
Intervention (5 months) Participants will be allocated to the Experimental Group (EG) and Control Group (CG) in a 1:1 ratio. In the EG, participants will be divided into small groups of 15 to 18 individuals. The exercise program, conducted at FADEUP, will run for 20 weeks, consisting of two 60-minute sessions per week at moderate to vigorous intensity. Heart rate monitors (GARMIN Vivosmart 4) and the Borg Rating of Perceived Exertion Scale (1 to 10) will be used to monitor intensity. The program will begin with a 3-week period at light intensity (57% to 63% of maximum heart rate), followed by a progression to moderate intensity (64% to 76%) from weeks 4 to 10, and to moderate-to-vigorous intensity (77% to 95%) from week 11 onward, with increasing complexity of exercises. The methodology is based on international training approaches from Polestar® and PhysicalMind® schools. The program includes Pilates exercises designed to improve trunk strength and stability (core), spinal mobility, upper and lower limb strength and flexibility, coordination, balance, agility, control, and concentration. The method emphasizes slow and controlled movements, focusing on both concentric and eccentric phases, with correct posture and movement quality. Dual-task exercises will be integrated into the Pilates routine, combining cognitive activities with physical tasks to promote attention and concentration. The selected Pilates exercises include: Cat, Swan, Mermaid, Spine Twist, Spine Stretch Forward, Squat, One Leg Circle, The Roll Down, The Roll Up, The Hundred, Single Leg Stretch, Double Leg Stretch, Bridge, Side Kick, Scissors, Bicycle, Scapular Support, Leg Pull Front, Leg Extension, Swimming, One Leg Kick, and Double Leg Kick. These exercises will be adapted for older adults using chairs, elastic bands, foam rollers, sticks, and balls to increase intensity and complexity.
Data analysis and processing Data will be entered into a database using SPSS (Statistical Package for the Social Sciences, version 29) and subsequently processed and analyzed. Descriptive statistics will be presented as medians and interquartile ranges or means and standard deviations, as well as counts and percentages, as appropriate. ANCOVA and repeated measures ANOVA will be used to compare differences between groups and time points. A 95% confidence interval will be applied. Only data from participants with an attendance rate of 75% or higher will be included in the analysis.
Dissemination of results This intervention is part of a doctoral project and will adhere to the principles of the Declaration of Helsink and the National Legislation. The results will be disseminated through four scientific articles and presentations at national and international conferences related to the study themes: physical and cognitive activity in older adults, Pilates, and fall risk.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Physical activity intervention (Pilates)

Arm	Type	Receives
Pilates	Experimental	Other: Pilates sectionsdepois
Control Group	No intervention	–

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Older adults (≥ 60 years)
Both sexes
Healthy (no diseases or diagnoses that prevent physical exercise)
Community-dwelling

Key exclusion criteria (3 listed)

Individuals diagnosed with medical conditions for which physical activity is not recommended, including, but not limited to, musculoskeletal problems, cardiovascular diseases, and/or severe respiratory diseases.
Participants with neurological diseases or disabling conditions that compromise balance.
Individuals with moderate or severe cognitive impairment, according to established normative test values.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pilates sectionsThis intervention combines Pilates with dual-task training over 20 weeks, featuring twice-weekly 60-minute sessions at moderate to vigorous intensity. It is uniquely grounded in methods from the Polestar and PhysicalMind schools and adapted for older adults (≥65 years), utilizing chairs, elastic bands, and minimal equipment. Unlike typical exercise programs, this protocol integrates cognitive tasks within Pilates exercises to simultaneously challenge physical and executive functions. Exercise intensity is individualized using heart rate monitors and the Borg scale. Assessments include trunk strength (Biodex System 4), balance (Biodex SD), and cognitive function (MoCA, Stroop, WAIS-III, TMT), making it one of the few trials to rigorously evaluate physical, cognitive, and dual-task performance outcomes in older adults. This approach is low-cost, scalable, and focused on fall prevention and autonomy maintenance.	Other	Pilates

Primary outcome

Balance- Biodex balance System SD
Time frame: Baseline, post 20 weeks.
The Biodex Balance System SD plataform was used to assess balance through the Sensory Integration Test (CTSIB) and the Falls Risk Test. These assessments evaluate how the central nervous system processes sensory inputs (visual, and proprioceptive systems) to maintain postural control, helping to identify balance impairments and fall risk (Biodex Medical Systems, Shirley, NY).
Stability of the trunk muscles- Stabilzer Pressure Biofeedback Unit
Time frame: Baseline, post 20 weeks
The study by Grooms et al. (2013) evaluated trunk muscle stability using the Stabilizer Pressure Biofeedback Unit, a device that measures the activation of deep abdominal muscles during exercises. It helps ensure proper engagement of core stabilizers, such as the transversus abdominis and multifidus, making it useful for both assessment and rehabilitation.
Balance- Single-Leg Stance Test
Time frame: Baseline, post 20 weeks.
The Single-Leg Stance Test is a simple and widely used method for assessing static postural balance. It involves standing on one leg, with eyes open, for up to 45 seconds. This test has been validated by Springer et al. (2007), who demonstrated its reliability in detecting balance deficits and fall risk, particularly in older adults and clinical populations.
Functional Fitness (Strength)- SFT
Time frame: Baseline; 20 weeks (post-intervention); 36 weeks (after 16-week detraining); 56 weeks (after second 20-week intervention in a subgroup)
The Senior Fitness Test includes specific assessments for upper and lower body strength in older adults. Lower body strength is measured using the 30-second chair stand test, which evaluates leg strength and endurance. Upper body strength is assessed with the 30-second arm curl test, measuring arm muscle strength. These tests were validated by Rikli and Jones (1999) and are considered reliable indicators of functional fitness in elderly populations.
Functional Fitness (Flexibility)- SFT
Time frame: Beseline, post 20 weeks.
The Senior Fitness Test includes two flexibility assessments aimed at older adults: the Sit and Reach Test, which evaluates lower body flexibility, particularly of the hamstrings and lower back; and the Back Scratch Test, which assesses upper body flexibility, focusing on shoulder mobility. Both tests were validated by Rikli and Jones (1999) and are widely used to detect limitations in functional range of motion.
Cardiorespiratory endurance- SFT
Time frame: Baseline, post 20 weeks.
The 6-Minute Walk Test is part of the Senior Fitness Test and evaluates cardiorespiratory endurance in older adults. Participants are instructed to walk as far as possible in six minutes along a 50-meter rectangular course. This test was validated by Rikli and Jones (1999) and is considered an excellent indicator of functional capacity for daily activities, such as climbing stairs or performing household tasks.
Dynamic balance and agility- 8-Foot Up-and-Go Test
Time frame: Baseline, post 20 weeks.
The 8-Foot Up-and-Go Test is part of the Senior Fitness Test and assesses agility and dynamic balance in older adults. The participant must stand up from a chair, walk 2.44 meters (8 feet) quickly, turn around a cone, and return to the seat as fast as possible (Rikli and Jones, 1999).
Handgrip strength
Time frame: Baseline, 20 weeks.
Handgrip strength was assessed using the Jamar analog dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA), a gold-standard instrument widely used to measure upper limb strength. The test is simple, quick, and provides a reliable indicator of overall functional strength. The Jamar dynamometer has well-established validity in clinical research.
Trunk strength- Biodex System 4 Pro isokinetic dynamometer
Time frame: Baseline; 20 weeks (post-intervention); 36 weeks (after 16-week detraining); 56 weeks (after second 20-week intervention in a subgroup)
Trunk strength was assessed using the Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA), a highly accurate device used to measure muscular torque and power at various speeds. It is widely used in clinical and research settings to analyze muscular performance in a standardized and safe manner.

9 secondary outcomes

Cognitive function- MoCA
Time frame: Baseline, 20 weeks.
Cognitive function- Trail Making Test
Time frame: Baseline, 20 weeks.
Cognitive function- Stroop Color and Word Test
Time frame: Baseline, 20 weeks.
General intelligence- Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: Baseline, 20 weeks
Cognitive function- Memory function
Time frame: Baseline, 20 weeks.
Sociodemographic questionnaire and and clinical characterization
Time frame: Baseline, 20 weeks.
Height assessment
Time frame: Baseline, 20 weeks
Body mass
Time frame: Baseline, 20 weeks.
Bone mineral density
Time frame: Baseline; 20 weeks (post-intervention); 36 weeks (after 16-week detraining); 56 weeks (after second 20-week intervention in a subgroup)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Results publicationGarcía-Vaquero, M. P., García-Manso, J. M., Pérez-López, J., Olcina, G., & Molinero, O. (2016). Reliability and learning effects of an isokinetic trunk extension-flexion protocol using the Biodex System 4. Clinical Biomechanics, 31, 627-630. https://doi.org/10.1016/j.clinbiomech.2016.05.003
Results publicationReitan, R. M. (1958). Validity of the Trail Making Test as an Indicator of Organic Brain Damage. Perceptual and Motor Skills, 8(3), 271-276. https://doi.org/10.2466/pms.1958.8.3.271 (Original work published 1958)
Results publicationStroop, J. R. (1935). Studies of interference in serial verbal reactions. Journal of Experimental Psychology, 18(6), 643-662. https://doi.org/10.1037/h0054651
Results publicationIntertester and intratester reliability of a dynamic balance protocol using the Biodex Stability System. Journal of Sport Rehabilitation, 7(2), 95-101. https://doi.org/10.1123/jsr.7.2.95
Results publication: PubMed 19839175Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.
Results publicationWechsler, D. (1997). WAIS-III: Wechsler Adult Intelligence Scale - Third Edition Manual. San Antonio, TX: The Psychological Corporation.
Results publication: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
Individual participant dataSharing planned: No. Data management will comply with applicable data protection legislation and the internal guidelines of the University of Porto. All project-specific documents, including collected data, will be stored with full privacy and confidentiality, with access restricted to the principal investigator and their advisors. The data will be destroyed after the objectives of the study are fulfilled or after five years, whichever comes first. All information obtained through questionnaires and direct observation will be anonymized before storage.

Related trials for Healthy People Programs

Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
Serious Mental Illness, Older Adults
Recruiting
Healthy Aging in People With Epilepsy Program
Epilepsy
Not yet recruiting
Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis
Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis
Recruiting
Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
Ageing

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joana Carvalho, PhD study director

CIAFEL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pilates sections in people with Healthy People Programs, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance- Biodex balance System SD (time frame: Baseline, post 20 weeks.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07119762, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.