Clinical Pilates Programme on People With COPD Gold A: a Rehabilitation Nursing Approach.

NCT ID: NCT07267858

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2026-07-24

Brief Summary

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The main objective of this study is to evaluate the effects of a Clinical Pilates-based exercise programme on chest mobility, lung function, motor performance, physical activity levels, sleep quality and Health-Related Quality of Life (HRQoL) in individuals with Gold A COPD. Based on our research question, 'What is the effect of a Clinical Pilates programme on thoracic mobility, pulmonary function, motor performance, physical activity levels, sleep quality, and HRQoL in people with Gold A COPD?', we propose the following research hypotheses:

H1: The Clinical Pilates programme contributed to improved thoracic mobility in people with Gold A COPD.

H2: The Clinical Pilates programme contributed to improved lung function in people with Gold A COPD.

H3: The Clinical Pilates programme positively influences the motor performance of people with Gold A COPD.

H4: The Clinical Pilates programme positively influences the physical activity levels of people with COPD Gold A.

H5: The Clinical Pilates programme positively influences the sleep quality of people with COPD Gold A.

H6: The Clinical Pilates programme contributes to improving the HRQoL levels of people with COPD Gold A.

Detailed Description

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Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sample of participants, divided into an experimental group and a control group:

1. Clinical Pilates Group (CPG), a group of people receiving follow-up rehabilitation nursing consultations and participating in the CP programme, which included 20 people.
2. Control Group (CG), a group that only underwent follow-up rehabilitation nursing consultations, in which 18 people participated.

Randomisation was performed by organising the individuals who met the inclusion criteria in alphabetical order and alternately removing them for each of the groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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Clinical Pilates Group (CPG)

Group of individuals with ongoing rehabilitation nursing consultations who participate in the CP programme consisting of 16 sessions of 60 minutes each.

Group Type EXPERIMENTAL

Clinical Pilates for people with COPD Gold A.

Intervention Type BEHAVIORAL

8-week programme with face-to-face sessions twice a week, lasting approximately 60 minutes per session, using equipment such as soft balls and elastic bands.

Control Group (CG)

Group that only underwent follow-up rehabilitation nursing consultations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clinical Pilates for people with COPD Gold A.

8-week programme with face-to-face sessions twice a week, lasting approximately 60 minutes per session, using equipment such as soft balls and elastic bands.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Anyone diagnosed with COPD at GOLD stage A, duly identified in SClínico, registered with the USF and residing in the geographical area covered by the Guimarães UCC, whose participation is validated by their family doctor. Inclusion in the study implies participation in at least 60% of the programme sessions, namely 10.

Exclusion Criteria

* People with a history of exacerbation of the disease less than 4 weeks ago, as the guidelines of the European Respiratory Society and the American Thoracic Society (2017) make a conditional recommendation on pulmonary rehabilitation after exacerbation and recommend waiting at least 3 weeks, severe osteoarticular limitation that prevents physical exercise, psychiatric illness or severe cognitive dysfunction, unstable comorbidities such as unstable ischaemic disease or decompensated heart failure, and exercise-induced hypoxemia refractory to oxygen administration.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidade Local de Saúde do Alto Ave, EPE

OTHER

Sponsor Role collaborator

University of Trás-os-Montes and Alto Douro

OTHER

Sponsor Role lead

Responsible Party

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Cristiana Marques

Enfermeira Cristiana Marques

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Unidade de Cuidados na Comunidade de Guimarães

Guimarães, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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142/2024-CAF

Identifier Type: -

Identifier Source: org_study_id

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