NCT07674251

Brief Summary

This study is a comparative interventional trial designed to evaluate the effects of Aquatic Pilates versus Mat Pilates on respiratory function, functional capacity, quality of life, and thoracic kyphosis in older women. Thoracic kyphosis is a common postural deviation in older adults that may negatively affect respiratory mechanics, physical performance, and quality of life. Participants were allocated into four groups and assessed at three time points: baseline (pre-intervention), after 6 weeks of intervention, and immediately following the completion of a 12-week exercise program. Outcome measures included anthropometric characteristics (height, body weight, and body mass index), degree of thoracic kyphosis, respiratory function assessed via spirometric testing, functional capacity evaluated using standardized physical performance tests, and quality of life. The intervention programs consisted of structured Aquatic Pilates and Mat Pilates protocols designed to improve postural alignment, respiratory efficiency, functional ability, and overall quality of life. The objective of the study is to compare the effectiveness of Aquatic Pilates versus Mat Pilates on respiratory, functional, and quality-of-life outcomes in older women with thoracic kyphosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

June 13, 2026

Last Update Submit

July 5, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Vital Capacity (VC)

    Vital Capacity (VC) measured by spirometry using the SPIROANALYZER ST-95 spirometer. VC is reported in liters (L). Higher values indicate better pulmonary function.

    Baseline, 6 weeks, and 12 weeks

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity (FVC) measured by spirometry using the SPIROANALYZER ST-95 spirometer. FVC is reported in liters (L). Higher values indicate better pulmonary function.

    Baseline, 6 weeks, and 12 weeks

  • Thoracic Kyphosis Angle

    Thoracic kyphosis angle measured using a kyphometer between T2 and T12 vertebrae. Results are reported in degrees (°). Lower values indicate reduced thoracic kyphosis.

    Baseline, 6 weeks, and 12 weeks

  • Timed Up and Go Test (TUG)

    Time required to stand up from a chair, walk 3 meters, return, and sit down. Measured in seconds. Lower scores indicate better mobility and functional performance.

    Baseline, 6 weeks, and 12 weeks

  • 4-Meter Gait Speed Test

    Gait speed calculated over a 4-meter walking distance and reported in meters per second (m/s). Higher scores indicate better walking performance.

    Baseline, 6 weeks, and 12 weeks

  • 6-Minute Walk Test (6MWT)

    Total distance walked during the 6-minute walk test. Reported in meters (m). Higher scores indicate better aerobic capacity and endurance.

    Baseline, 6 weeks, and 12 weeks

  • Modified Physical Performance Test (mPPT) Score

    Functional performance assessed using the Modified Physical Performance Test (mPPT). Higher scores indicate better functional capacity and physical performance.

    Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (6)

  • Short Form-36 Health Survey (SF-36) Score

    Baseline, 6 weeks, and 12 weeks

  • PROMIS Global Health Scale v1.2

    Baseline, 6 weeks, and 12 weeks

  • Physical Activity Scale for the Elderly (PASE) Score

    Baseline, 6 weeks, and 12 weeks

  • Body weight

    Baseline, 6 weeks, and 12 weeks

  • Ηeight

    Baseline, 6 weeks, and 12 weeks

  • +1 more secondary outcomes

Study Arms (4)

Aquatic Pilates Group

EXPERIMENTAL

Participants completed a structured Aquatic Pilates exercise program over 12 weeks, consisting of 24 sessions performed twice weekly, with each session lasting 45 minutes. Exercise intensity was maintained at a light-to-moderate level according to established guidelines (ACSM Guidelines for Exercise Testing and Prescription, 2018). The program focused on core stabilization, postural alignment, spinal control, and coordinated breathing patterns. Exercises were performed in a water environment, utilizing buoyancy and hydrostatic resistance.

Behavioral: Aquatic Pilates

Mat Pilates Group

EXPERIMENTAL

Participants completed a structured Mat Pilates exercise program over 12 weeks, consisting of 24 sessions performed twice weekly, with each session lasting 45 minutes. Exercise intensity was maintained at a light-to-moderate level according to established guidelines (ACSM Guidelines for Exercise Testing and Prescription, 2018). The program focused on core stabilization, postural alignment, spinal control, and coordinated breathing patterns. Exercises were performed on land using a mat-based Pilates protocol.

Behavioral: Mat Pilates

Kyphosis Control Group

NO INTERVENTION

Participants with thoracic kyphosis did not receive any structured exercise intervention and were instructed to maintain their usual daily activities throughout the 12-week study period. They were assessed at the same time points as the intervention groups.

Healthy Control Group

NO INTERVENTION

Healthy older adults without thoracic kyphosis did not participate in any structured exercise program and maintained their usual daily activities during the study period. They were included as a reference comparison group and assessed at identical time points as the other groups.

Interventions

Aquatic PilatesBEHAVIORAL

A structured 12-week Aquatic Pilates exercise program consisting of 24 sessions performed twice weekly. The intervention involved controlled exercise in a water environment utilizing buoyancy and hydrostatic resistance.

Also known as: Water-based Pilates
Aquatic Pilates Group
Mat PilatesBEHAVIORAL

A structured 12-week Mat Pilates exercise program consisting of 24 sessions performed twice weekly. The intervention was conducted on land using a mat-based Pilates protocol focusing on controlled movement and postural control.

Also known as: Land-based Pilates
Mat Pilates Group

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants
  • Αge 55-65 years
  • Clinical diagnosis of thoracic kyphosis
  • Thoracic kyphosis angle between 26° and 46°
  • Ability to participate in exercise program
  • Ability to provide written informed consent

You may not qualify if:

  • Rheumatoid arthritis
  • Chronic obstructive pulmonary disease (COPD)
  • Cardiovascular disease
  • History of spinal surgery
  • History of lower limb surgery
  • Recent fractures within the past 6 months
  • Severe hyperkyphosis (\>46°)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipal Indoor Swimming Pool of Karpenisi

Karpenisi, Evrytania, 36100, Greece

Location

Study Officials

  • HELEN SOULTANAKIS, Dr

    National and Kapodistrian University of Athens, School of Physical Education and Sport Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 29, 2026

Study Start

January 2, 2025

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations