NCT07650929

Brief Summary

This randomized controlled trial evaluated whether adding diaphragmatic breathing exercises to an eight-week supervised Pilates program improves pulmonary function, resting heart rate, and core endurance in sedentary women aged 35 years and older. Participants were randomized to Pilates combined with diaphragmatic breathing or Pilates alone. Both groups trained three times per week for eight weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Pilates Diaphragmatic Breathing Pulmonary Function Sedentary Women Resting Heart Rate Core Endurance Peak Expiratory Flow

Outcome Measures

Primary Outcomes (1)

  • Change in Peak Expiratory Flow

    Peak expiratory flow was assessed by spirometry. The change from baseline to the end of the eight-week intervention was evaluated.

    Baseline and after 8 weeks

Secondary Outcomes (6)

  • Change in Forced Vital Capacity

    Baseline and after 8 weeks

  • Change in Forced Expiratory Volume in One Second

    Baseline and after 8 weeks

  • Change in FEV1/FVC Ratio

    Baseline and after 8 weeks

  • Change in Resting Heart Rate

    Baseline and after 8 weeks

  • Change in Plank Test Performance

    Baseline and after 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Pilates Exercise Diaphragmatic Breathing Exercise

EXPERIMENTAL

Participants completed an eight-week supervised Pilates program combined with structured diaphragmatic and abdominal breathing exercises. Sessions were performed three times per week and lasted approximately 60 minutes.

Behavioral: Pilates Exercise ProgramBehavioral: Diaphragmatic Breathing Exercise

Pilates Alone

ACTIVE COMPARATOR

Participants completed the same eight-week supervised Pilates program without specific diaphragmatic breathing instruction. Sessions were performed three times per week and lasted approximately 60 minutes.

Behavioral: Pilates Exercise Program

Interventions

Participants performed structured diaphragmatic and abdominal breathing exercises integrated into the Pilates sessions. The breathing protocol included slow nasal inhalation, controlled oral exhalation, abdominal expansion, segmental thoracic breathing, and guided breathing rhythm during selected Pilates exercises.

Pilates Exercise Diaphragmatic Breathing Exercise

Participants completed a supervised mat-based Pilates exercise program three times per week for eight weeks. Each session lasted approximately 60 minutes and included a warm-up phase, a main Pilates exercise component targeting core stability, flexibility, postural alignment, and muscular endurance, and a cool-down phase.

Pilates AlonePilates Exercise Diaphragmatic Breathing Exercise

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as women are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants aged 35 years or older
  • Sedentary status, defined as no regular structured exercise participation during the previous six months
  • Non-smoker
  • No diagnosed cardiovascular, pulmonary, or musculoskeletal disorder
  • Not using medications known to influence cardiopulmonary function
  • Provided written informed consent

You may not qualify if:

  • Pregnancy
  • Recent surgery or injury
  • Participation in another structured exercise program during the study period
  • Any cardiovascular, pulmonary, or musculoskeletal condition that could affect safe participation
  • Use of medication known to influence cardiopulmonary function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandirma Onyedi Eylul University, Faculty of Medicine

Balıkesir, Bandırma, 10010, Turkey (Türkiye)

Location

Study Officials

  • DUYGU DURMAZ, PHD

    Bandirma Onyedi Eylul University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation. Participants and exercise instructors could not be blinded because of the nature of the exercise intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1 ratio to one of two parallel intervention groups. The experimental group completed a supervised Pilates program combined with structured diaphragmatic breathing exercises, whereas the active comparator group completed the same supervised Pilates program without specific diaphragmatic breathing instruction. Both groups trained three times per week for eight weeks. Outcomes were assessed at baseline and after the intervention by assessors blinded to group allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bandirma Onyedi Eylul University, Faculty of Medicine

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start

June 3, 2025

Primary Completion

September 5, 2025

Study Completion

October 7, 2025

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the article will be made available upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning after publication and available for 5 years.
Access Criteria
Data will be shared with researchers who submit a methodologically sound proposal and obtain approval from the corresponding author and, if required, the institutional ethics committee.

Locations