NCT06479499

Brief Summary

This study aims to compare the effects of Pilates, with its emphasis on proper breathing and muscle activation, and aerobic exercises, known for improving cardiovascular fitness, on dyspnea, anxiety, and functional capacity in COPD patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 24, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

Aerobic exercises

Outcome Measures

Primary Outcomes (3)

  • Dyspnea

    The modified Medical Research Council scale (mMRC scale) is largely used in the assessment of dyspnea in chronic respiratory diseases. The mMRC scale is a 5-point (0-4) scale based on the severity of dyspnea. It is a quantitative assessment tool only for breathlessness. It assesses the effectiveness of treatment on an individual bass. Compare the effectiveness of a treatment within a population and Predict survival times and rates.

    8th weeks

  • Functional Capacity

    In the context of COPD functional capacity refers to a person's ability to perform daily activities and exercise without experiencing excessive shortness of breath or fatigue. It is an important measure to assess the function of a person with COPD therefore in present study it will be assessed by 6 minutes' walk distance.

    8th weeks

  • Anxiety

    The Self rating anxiety scale is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms. Answering the statements, a person should indicate how much each statement applies to him or her within a period of one or two weeks prior to taking the test. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time", "some of the time", "good part of the time", "most of the time"). Some questions are negatively worded to avoid the problem of set response. Overall assessment is done by total score.

    8th weeks

Study Arms (2)

Pilates exercises

EXPERIMENTAL

Group A will receive Pilates exercise with duration of 10-15 minutes and gradually progressing to 20-30 minutes. The session will hold 3 times per week over period of 8 weeks. It begins with warm-up and cool-down of about 5-10 minutes with rest interval of 1-2 minutes.

Other: Pilates Exercises

Aerobic exercise

EXPERIMENTAL

Group B will receive aerobic exercise it begins with a warm-up of 5-10 minutes. The duration of session will be 5-10 minutes in short interval of 1-2 minutes and then gradually reducing it to 30 seconds. The cool-down will be 5-10 minutes. The session will hold 3 times per week over period of 8 weeks.

Other: Aerobic Exercises

Interventions

Group A will undergo Pilates exercise training, scheduled three times weekly over an 8-week period, for elderly individuals with COPD the duration and time interval time for Pilates exercise can vary depending on their overall health, fitness level, and tolerance. It begins with warm-up with 10-15 minutes which may include gentle stretches and deep breathing Maintain proper breathing during exercise and gradually increase the intensity as the person becomes stronger. The exercise sessions lasting around 10-15 minutes and then gradually progressing to 20-30 minutes as the participants become more comfortable and their endurance improves. Maintain proper breathing during exercise and gradually increase the intensity as the person becomes stronger. The rest interval will be 1-2 minutes between exercise and then gradually reducing it to 30 seconds or less. Pilates session ends with a cool-down which may involve stretching and relaxation with duration of about 5-10 minutes.

Pilates exercises

Group B will engage in Aerobic exercise plan, following the same frequency and duration as the Pilates exercise program-three sessions per week for 8 weeks, It begins with a warm-up of 5-10 minutes to prepare body for exercise it includes gentle movements, stretching, or a few minutes of low-intensity aerobic activity. It includes main exercise with moderate intensity like brisk walking or jogging with duration of 5-10 minutes and increase to 20-30 minutes as participants improves their endurance. The short interval begins with 1-2 minutes than gradually reducing it to 30 seconds or less as a person builds up stamina and fitness. The cool-down duration at end of exercise will be 5-10 minutes.

Aerobic exercise

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The both male and female participants will be included in the study.
  • The age of included participants will be 45-65 years old.
  • Diagnosed COPD patients of stage 2-3 according to gold criteria (moderate)
  • When the patients started the exercise program, they were stable, and none of them showed any clinical signs of neuromuscular or cardiovascular conditions that would prevent them from exercising.
  • The selected participants are getting medical therapy with pulmonary medications.
  • Those participants who will sign a written informed consent form will be included in the study.

You may not qualify if:

  • Participants who had recent abdominal and chest surgeries will be excluded.
  • Patients having history of cardiac arrhythmias or potential ECG alterations,
  • Patients who are unable to follow commands.
  • Participants presented with severe neuro-musculoskeletal abnormalities.
  • The chosen individuals were smokers or former smokers with a medical history of COPD; none of them exhibited any physiological or clinical signs of bronchial asthma.
  • No involvement in a consistent workout regimen for a minimum of six months before the study's start.
  • Those participants who are doing Yoga.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Exercise Movement TechniquesExercise

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tasneem Shehzadi, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasneem Shehzadi, Mphil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

November 23, 2023

Primary Completion

June 18, 2024

Study Completion

June 18, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations