COPD PatientsNCT06479499
Effects of Pilate Versus Aerobic Exercises on Dyspnea , Functional Capacity and Anxiety Status in Patients With COPD
A study testing Pilates Exercises and Aerobic Exercises in people with COPD Patients, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- COPD Patients
- What is being tested?
- Pilates Exercises and Aerobic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Nov 2023to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah international university
Lahore, Punjab Province, 54000
Tasneem Shehzadi, Mphil, 03104108327, Tasneem.shezadi@riphah.edu.pk
Tasneem Shehzadi, Mphil, 03104108327, Tasneem.shezadi@ripha.edu.pk
About this study
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.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) poses a significant public health burden, with rising mortality rates and increased disability-adjusted life years. Common symptoms include dyspnea, chronic cough, and chest tightness, often exacerbated by factors like cigarette smoke and air pollution. Functional capacity becomes a notable concern, marked by exercise intolerance and muscle deconditioning due to COPD's characteristic airflow limitation. Anxiety, linked to breathlessness and the chronic nature of COPD, further complicates the interplay, restricting functional capacity and social involvement. Holistic management, including pulmonary rehabilitation, recognizes these challenges. 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.
Participants in a research study will be informed and provide voluntary consent before undergoing an 8-week intervention involving Pilates or aerobic exercise, alongside conventional treatments. The study aims to improve respiratory function and overall well-being, with data collected on demographics, primary, and secondary outcomes. Statistical analysis, conducted using SPSS, will include descriptive statistics, paired sample t-tests and Man Witney test. The study adheres to ethical guidelines, ensuring participant rights and welfare. Overall, it seeks to comprehensively analyze the impact of exercise interventions on respiratory health and quality of life through rigorous statistical methods and visualization.
- Conditions
- COPD Patients
- Being tested
- Pilates Exercises, Aerobic Exercises
- Keywords
- Aerobic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExercisesOther
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.
Aerobic ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start23 Nov 2023
- Primary completion18 Jun 2024 (estimated)
- Study completion18 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD PatientsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tasneem Shehzadi, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479499
- Sponsor's protocol ID
- REC/RCR & AHS/23/0367
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilate Versus Aerobic Exercises on Dyspnea , Functional Capacity and Anxiety Status in Patients With COPD
- ClinicalTrials.gov ID
- NCT06479499
- Acronym / sponsor ID
- REC/RCR & AHS/23/0367
- Conditions
- COPD Patients
- Keywords
- Aerobic exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 18 Jun 2024 (estimated)
- Study completion
- 18 Jun 2024 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) poses a significant public health burden, with rising mortality rates and increased disability-adjusted life years. Common symptoms include dyspnea, chronic cough, and chest tightness, often exacerbated by factors like cigarette smoke and air pollution. Functional capacity becomes a notable concern, marked by exercise intolerance and muscle deconditioning due to COPD's characteristic airflow limitation. Anxiety, linked to breathlessness and the chronic nature of COPD, further complicates the interplay, restricting functional capacity and social involvement. Holistic management, including pulmonary rehabilitation, recognizes these challenges. 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.
Participants in a research study will be informed and provide voluntary consent before undergoing an 8-week intervention involving Pilates or aerobic exercise, alongside conventional treatments. The study aims to improve respiratory function and overall well-being, with data collected on demographics, primary, and secondary outcomes. Statistical analysis, conducted using SPSS, will include descriptive statistics, paired sample t-tests and Man Witney test. The study adheres to ethical guidelines, ensuring participant rights and welfare. Overall, it seeks to comprehensively analyze the impact of exercise interventions on respiratory health and quality of life through rigorous statistical methods and visualization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercises | Experimental | Other: Pilates ExercisesGroup 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. |
| Aerobic exercise | Experimental | Other: Aerobic ExercisesGroup 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates ExercisesGroup 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. | Other | Pilates exercises |
| Aerobic ExercisesGroup 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. | Other | Aerobic exercise |
Primary outcome
Dyspnea
Time frame: 8th weeks
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.
Functional Capacity
Time frame: 8th weeks
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.
Anxiety
Time frame: 8th weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for COPD Patients
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasneem Shehzadi, Mphil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises and Aerobic Exercises in people with COPD Patients, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tasneem Shehzadi, Mphil (03104108327, Tasneem.shezadi@ripha.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 8th weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.