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

NCT07119762 | Active Not Recruiting DMC

• 2 other identifiers: CEFADE 41_20222023.02364.BD
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy People Programs

Keywords

AGING.; PHYSICAL EXERCISE; CORE STRENGTH; STABILITY

Outcome Measures

Primary Outcomes (9)

• 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).

  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.

  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.

  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.

  Baseline, 20 weeks.

• 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.

  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.

  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).

  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.

  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.

  Baseline, 20 weeks

Secondary Outcomes (9)

• Cognitive function- MoCA

  Baseline, 20 weeks.

• Cognitive function- Trail Making Test

  Baseline, 20 weeks.

• Cognitive function- Stroop Color and Word Test

  Baseline, 20 weeks.

• General intelligence- Wechsler Adult Intelligence Scale (WAIS-III)

  Baseline, 20 weeks

• Cognitive function- Memory function

  Baseline, 20 weeks.

Other Outcomes (1)

• Habitual physical activityBaseline, 20 weeks.

  Baseline, 20 weeks.

Study Arms (2)

Pilates

EXPERIMENTAL

depois

Other: Pilates sections

Control Group

NO INTERVENTION

Interventions

Pilates sections 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.

Pilates

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

CIAFEL

Porto, Porto District, Portugal

Location

Related Publications (7)

• 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

  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)

  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

  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

  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.

  PMID: 19839175 BACKGROUND

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

  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.

  PMID: 15817019 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joana Carvalho, PhD

  CIAFEL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Physical activity intervention (Pilates)

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: April 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)