- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07674251
Aquatic vs Mat Pilates for Thoracic Kyphosis in Older Women (AMPKOW)
The Effect of Therapeutic Aquatic Exercise on the Improvement of Respiratory and Functional Capacity in Older Adults With Kyphosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Evrytania
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Karpenisi, Evrytania, Greece, 36100
- Municipal Indoor Swimming Pool of Karpenisi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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°)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aquatic Pilates Group
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.
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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.
Other Names:
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Experimental: Mat Pilates Group
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.
|
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.
Other Names:
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No Intervention: Kyphosis Control Group
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.
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|
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No Intervention: Healthy Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vital Capacity (VC)
Time Frame: Baseline, 6 weeks, and 12 weeks
|
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
|
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Forced Vital Capacity (FVC)
Time Frame: Baseline, 6 weeks, and 12 weeks
|
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.
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Baseline, 6 weeks, and 12 weeks
|
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Thoracic Kyphosis Angle
Time Frame: Baseline, 6 weeks, and 12 weeks
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Thoracic kyphosis angle measured using a kyphometer between T2 and T12 vertebrae.
Results are reported in degrees (°).
Lower values indicate reduced thoracic kyphosis.
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Baseline, 6 weeks, and 12 weeks
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Timed Up and Go Test (TUG)
Time Frame: Baseline, 6 weeks, and 12 weeks
|
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
|
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4-Meter Gait Speed Test
Time Frame: Baseline, 6 weeks, and 12 weeks
|
Gait speed calculated over a 4-meter walking distance and reported in meters per second (m/s).
Higher scores indicate better walking performance.
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Baseline, 6 weeks, and 12 weeks
|
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6-Minute Walk Test (6MWT)
Time Frame: Baseline, 6 weeks, and 12 weeks
|
Total distance walked during the 6-minute walk test.
Reported in meters (m).
Higher scores indicate better aerobic capacity and endurance.
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Baseline, 6 weeks, and 12 weeks
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Modified Physical Performance Test (mPPT) Score
Time Frame: Baseline, 6 weeks, and 12 weeks
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Functional performance assessed using the Modified Physical Performance Test (mPPT).
Higher scores indicate better functional capacity and physical performance.
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Baseline, 6 weeks, and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form-36 Health Survey (SF-36) Score
Time Frame: Baseline, 6 weeks, and 12 weeks
|
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36).
Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
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Baseline, 6 weeks, and 12 weeks
|
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PROMIS Global Health Scale v1.2
Time Frame: Baseline, 6 weeks, and 12 weeks
|
Health-related quality of life assessed using the PROMIS Global Health Scale v1.2.
Results are reported as T-scores with a population mean of 50 and standard deviation of 10.
Higher scores indicate better perceived health status.
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Baseline, 6 weeks, and 12 weeks
|
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Physical Activity Scale for the Elderly (PASE) Score
Time Frame: Baseline, 6 weeks, and 12 weeks
|
Physical activity assessed using the Physical Activity Scale for the Elderly (PASE).
Total scores typically range from 0 to over 400, with higher scores indicating greater levels of physical activity.
|
Baseline, 6 weeks, and 12 weeks
|
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Body weight
Time Frame: Baseline, 6 weeks, and 12 weeks
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Body weight measured in kilograms (kg) using a calibrated scale
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Baseline, 6 weeks, and 12 weeks
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Ηeight
Time Frame: Baseline, 6 weeks, and 12 weeks
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Height measured using a standard wall-mounted height measuring device
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Baseline, 6 weeks, and 12 weeks
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Βody Μass Ιndex (BMI)
Time Frame: Baseline, 6 weeks, and 12 weeks
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Calculated as weight (kg) divided by height squared (m²) (kg/m²)
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Baseline, 6 weeks, and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: HELEN SOULTANAKI, Dr, National and Kapodistrian University of Athens, School of Physical Education and Sport Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- AQUA-PILATES-KYPHOSIS-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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