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

NCT ID: NCT07119762

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-04-30

Brief Summary

Our aims are to evaluate the impact of 24-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.

Detailed Description

To accomplish our aims the following tasks will be conducted:

1. 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%.

2. 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.

3. 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.

4. 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.

5. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pilates

depois

Group Type: EXPERIMENTAL

Pilates sections

Intervention Type: OTHER

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.

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pilates sections

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joana Carvalho, PhD

Role: STUDY_DIRECTOR

CIAFEL

Locations

CIAFEL

Porto, Porto District, Portugal

Countries

Portugal

References

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

Reference Type: BACKGROUND

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)

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19839175 (View on PubMed)

Wechsler, D. (1997). WAIS-III: Wechsler Adult Intelligence Scale - Third Edition Manual. San Antonio, TX: The Psychological Corporation.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 15817019 (View on PubMed)

Other Identifiers

2023.02364.BD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CEFADE 41_2022

Identifier Type: -

Identifier Source: org_study_id