Diabetes Type IINCT07290231
Effects of Core Strengthening Exercises With Diapgragmatic Breathing Versus Core Strengthening Exercises With Pilate Breathing in Diabetes Type II Patients
A study testing Core Strengthening with Diaphragmatic Breathing and core strengthening with pilate breathing in people with Diabetes Type II, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Diabetes type II is a metabolic syndrome involving high sugar levels known as hyperglycemia. It can impair pulmonary function through reduced lung elasticity and gas exchange and weaken core muscles due to inflammation and muscle atrophy. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Diabetes Type II
- What is being tested?
- Core Strengthening with Diaphragmatic Breathing and core strengthening with pilate breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Aug 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically diagnosed patients with Type II diabetes confirmed by a medical specialist, general practitioner, or endocrinologist from FFH or private hospital settings in Rawalpindi and Islamabad.
- Age between 30 and 55 years.
- Both male and female patients.
- Willingness to participate in the exercise program and ability to provide informed consent.
- On a stable regimen of anti-diabetic medications for at least three months prior to the study.
Who cannot join
- Patients with Type I diabetes, diabetes insipidus, or gestational diabetes.
- Diagnosed chronic respiratory diseases such as COPD or asthma unrelated to diabetes.
- History of any abdominal, orthopedic, or spinal surgery that could interfere with balance.
- Uncontrolled cardiovascular conditions such as arrhythmias or recent myocardial infarction.
- Morbid obesity (BMI > 40).
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy, Islamabad, 44000
Islamabad
About this study
Diabetes type II is a metabolic syndrome involving high sugar levels known as hyperglycemia. It can impair pulmonary function through reduced lung elasticity and gas exchange and weaken core muscles due to inflammation and muscle atrophy. Literature has shown the individual effects of these exercises on quality of life. However, no study has yet evaluated the combined effects of these exercises on different variables such as lung function, functional capacity, and blood sugar levels.
OBJECTIVE: The objective of this study is to compare the effects of diaphragmatic breathing and Pilates breathing, combined with core strengthening exercises, on lung function, functional capacity, blood sugar levels, and quality of life. The study aims to determine which breathing technique provides greater physiological and functional benefits.
Read more
METHOD: The study will be a Randomized control trial consisting of two groups subjects meeting the inclusion criteria will be selected for the study. The subjects will then be randomly assigned to two groups. One group will receive Diaphragmatic breathing with core strengthening exercises and other group will receive Pilate breathing with core strengthening exercises. Before initiating the treatment procedure following would be assessed for all the patients: Pulmonary Function, Functional Capacity, Blood sugar levels and quality of life. Afterwards a treatment regime distributed over the course of six weeks will be given to all patients. After the interventions Pulmonary function, Functional capacity, Blood sugar levels and Quality of life would be reassessed. Data would be analyzed to evaluate the outcomes.
DATA COLLECTION PROCEDURE: The participants eligible for the study according to inclusion and exclusion criteria would be recruited for the study voluntarily and referred from Medical OPD of Fauji Foundation Hospital and Rehab OPD of Fauji Foundation Hospital. The purpose of this study along with the treatment plan would be explained to the participants in the language they understand their best and informed consent will be taken from the participants. A treatment regimen consisting of 18 weeks distributed over the course of six weeks will be provided to the patients in multidisciplinary lab of foundation University College of physical therapy
Read the detailed description
Diabetes type II is an expanding global problem linked to several factors such as obesity, unhealthy diet, and physical inactivity. The two most common causes are impaired insulin secretion or insulin resistance. Diabetes type II is a major health burden for the elderly population, affecting approximately 25% of individuals over the age of 65 years. Recently, increased attention has been paid to the loss of muscle power and sarcopenia in individuals with type II diabetes, as these conditions compromise both physical and psychological health, significantly affecting overall quality of life. Diabetes type II is a heterogeneous disorder affecting multiple organs. The alveolar capillary network, a large microvascular unit in the lungs, may be associated with the condition. Functional capacity is a strong predictor of survival in many diseases, including diabetes type II. Patients are more likely to experience functional impairments due to poor glycemic control and associated complications. Symptoms such as inadequate metabolic control, episodes of hypoglycemia, fear of hypoglycemia, and changes in lifestyle collectively lead to poor health-related quality of life, with reductions in functional performance. Activities of daily living and overall quality of life are often most affected by vascular complications in diabetes type II. Reduced lung function and impaired gas transfer are also linked to the disease. Chronic hyperglycemia causes the production of reactive oxygen species due to a process known as non-protein enzymatic glycation. Advanced glycation and continuous oxidative stress trigger a chronic inflammatory response. Additionally, there is a considerable decrease in glucose uptake in the skeletal muscles of patients with diabetes type II. Due to impaired insulin production and utilization, patients experience a constant state of elevated blood sugar levels that can lead to severe short-term and long-term consequences. Diabetes type II, therefore, represents a complex disorder characterized by defects in insulin production and utilization. Research also indicates that diets containing high sugar content, refined foods, and high-calorie foods significantly increase the risk of developing diabetes type II.
This study aims to explore the combined effects of treatment regimens on pulmonary function, functional capacity, random blood sugar levels, and quality of life. The investigation seeks to provide a deeper understanding of the effects of these interventions on various health variables.
- Conditions
- Diabetes Type II
- Being tested
- Core Strengthening with Diaphragmatic Breathing, core strengthening with pilate breathing
- Keywords
- core strengthening exercises, Pilate breathing exercises, diaphragmatic breathing exercises, Type II Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Strengthening with Diaphragmatic BreathingOther
Swiss Ball Seated Marching: Sit on the ball with feet flat on the floor, hip-width apart. Keep the back straight and core engaged. Slowly lift right foot a few inches off the ground. Hold for 1-2 seconds, then lower. Lift left foot the same way. Continue alternating in a slow, controlled motion.
core strengthening with pilate breathingOther
Pilates Breathing Sit/lie in neutral spine, hand on ribs \& stomach. Inhale through nose, expand ribs (not shoulders). Exhale, draw navel to spine, engage core. Core Strengthening Abdominal Bracing: Tighten abs, hold while breathing. Pelvic Tilt: Flatten lower back, lift tailbone slightly. Hold 5-10s. Dead Bug: Lower opposite arm \& leg, return. Alternate. Quadruped (Bird Dog): On all fours, extend opposite arm \& leg. Hold 2-3s. Plank: Forearms down, straight body. Hold 20-60s. Bridge: Lift hips, squeeze glutes, lower slowly. Segmental Rolling: Roll with upper body first, then lower body. Swiss Ball Marching: Sit tall, lift one foot at a time.
| Study group | Role | What they receive |
|---|---|---|
| core strengthening with diaphragmatic breathing | Experimental | detailed components of core strengthening exercises and diaphragmatic breathing Receives: Other: Core Strengthening with Diaphragmatic Breathing |
| core strengthening with pilate breathing | Experimental | detailed components of core strengthening exercises and pilate breathing Receives: Other: core strengthening with pilate breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary Function
Pulmonary function will be assessed using spirometry following standard ATS/ERS procedures. Key parameters recorded will include FVC, FEV₁, and the FEV₁/FVC ratio. Spirometry will be used to evaluate baseline respiratory status and monitor any changes over time.
Measured: 6 weeks
Functional capacity
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk at their usual pace for six minutes along a standardized, measured corridor. The total distance walked (in meters) will be recorded as the outcome. Standardized encouragement and safety monitoring will be followed according to established guidelines.
Measured: 6 weeks
Blood sugar levels
Blood sugar level will be measured using a calibrated glucometer. A capillary blood sample will be obtained via finger-prick, and glucose concentration will be recorded in mg/dL according to standard operating procedures.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start6 Aug 2025
- Primary completion3 Jan 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type IIStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290231
- Sponsor's protocol ID
- FUI/CTR/2025/93
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Strengthening Exercises With Diapgragmatic Breathing Versus Core Strengthening Exercises With Pilate Breathing in Diabetes Type II Patients
- ClinicalTrials.gov ID
- NCT07290231
- Acronym / sponsor ID
- FUI/CTR/2025/93
- Conditions
- Diabetes Type II
- Keywords
- core strengthening exercises, Pilate breathing exercises, diaphragmatic breathing exercises, Type II Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 3 Jan 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
Diabetes type II is a metabolic syndrome involving high sugar levels known as hyperglycemia. It can impair pulmonary function through reduced lung elasticity and gas exchange and weaken core muscles due to inflammation and muscle atrophy. Literature has shown the individual effects of these exercises on quality of life. However, no study has yet evaluated the combined effects of these exercises on different variables such as lung function, functional capacity, and blood sugar levels.
OBJECTIVE: The objective of this study is to compare the effects of diaphragmatic breathing and Pilates breathing, combined with core strengthening exercises, on lung function, functional capacity, blood sugar levels, and quality of life. The study aims to determine which breathing technique provides greater physiological and functional benefits.
METHOD: The study will be a Randomized control trial consisting of two groups subjects meeting the inclusion criteria will be selected for the study. The subjects will then be randomly assigned to two groups. One group will receive Diaphragmatic breathing with core strengthening exercises and other group will receive Pilate breathing with core strengthening exercises. Before initiating the treatment procedure following would be assessed for all the patients: Pulmonary Function, Functional Capacity, Blood sugar levels and quality of life. Afterwards a treatment regime distributed over the course of six weeks will be given to all patients. After the interventions Pulmonary function, Functional capacity, Blood sugar levels and Quality of life would be reassessed. Data would be analyzed to evaluate the outcomes.
DATA COLLECTION PROCEDURE: The participants eligible for the study according to inclusion and exclusion criteria would be recruited for the study voluntarily and referred from Medical OPD of Fauji Foundation Hospital and Rehab OPD of Fauji Foundation Hospital. The purpose of this study along with the treatment plan would be explained to the participants in the language they understand their best and informed consent will be taken from the participants. A treatment regimen consisting of 18 weeks distributed over the course of six weeks will be provided to the patients in multidisciplinary lab of foundation University College of physical therapy
Detailed description
Diabetes type II is an expanding global problem linked to several factors such as obesity, unhealthy diet, and physical inactivity. The two most common causes are impaired insulin secretion or insulin resistance. Diabetes type II is a major health burden for the elderly population, affecting approximately 25% of individuals over the age of 65 years. Recently, increased attention has been paid to the loss of muscle power and sarcopenia in individuals with type II diabetes, as these conditions compromise both physical and psychological health, significantly affecting overall quality of life. Diabetes type II is a heterogeneous disorder affecting multiple organs. The alveolar capillary network, a large microvascular unit in the lungs, may be associated with the condition. Functional capacity is a strong predictor of survival in many diseases, including diabetes type II. Patients are more likely to experience functional impairments due to poor glycemic control and associated complications. Symptoms such as inadequate metabolic control, episodes of hypoglycemia, fear of hypoglycemia, and changes in lifestyle collectively lead to poor health-related quality of life, with reductions in functional performance. Activities of daily living and overall quality of life are often most affected by vascular complications in diabetes type II. Reduced lung function and impaired gas transfer are also linked to the disease. Chronic hyperglycemia causes the production of reactive oxygen species due to a process known as non-protein enzymatic glycation. Advanced glycation and continuous oxidative stress trigger a chronic inflammatory response. Additionally, there is a considerable decrease in glucose uptake in the skeletal muscles of patients with diabetes type II. Due to impaired insulin production and utilization, patients experience a constant state of elevated blood sugar levels that can lead to severe short-term and long-term consequences. Diabetes type II, therefore, represents a complex disorder characterized by defects in insulin production and utilization. Research also indicates that diets containing high sugar content, refined foods, and high-calorie foods significantly increase the risk of developing diabetes type II.
This study aims to explore the combined effects of treatment regimens on pulmonary function, functional capacity, random blood sugar levels, and quality of life. The investigation seeks to provide a deeper understanding of the effects of these interventions on various health variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core strengthening with diaphragmatic breathing | Experimental | Other: Core Strengthening with Diaphragmatic Breathingdetailed components of core strengthening exercises and diaphragmatic breathing |
| core strengthening with pilate breathing | Experimental | Other: core strengthening with pilate breathingdetailed components of core strengthening exercises and pilate breathing |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medically diagnosed patients with Type II diabetes confirmed by a medical specialist, general practitioner, or endocrinologist from FFH or private hospital settings in Rawalpindi and Islamabad.
- Age between 30 and 55 years.
- Both male and female patients.
- Willingness to participate in the exercise program and ability to provide informed consent.
- On a stable regimen of anti-diabetic medications for at least three months prior to the study.
Key exclusion criteria (6 listed)
- Patients with Type I diabetes, diabetes insipidus, or gestational diabetes.
- Diagnosed chronic respiratory diseases such as COPD or asthma unrelated to diabetes.
- History of any abdominal, orthopedic, or spinal surgery that could interfere with balance.
- Uncontrolled cardiovascular conditions such as arrhythmias or recent myocardial infarction.
- Morbid obesity (BMI > 40).
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 |
|---|---|---|
| Core Strengthening with Diaphragmatic BreathingSwiss Ball Seated Marching: Sit on the ball with feet flat on the floor, hip-width apart. Keep the back straight and core engaged. Slowly lift right foot a few inches off the ground. Hold for 1-2 seconds, then lower. Lift left foot the same way. Continue alternating in a slow, controlled motion. | Other | core strengthening with diaphragmatic breathing |
| core strengthening with pilate breathingPilates Breathing Sit/lie in neutral spine, hand on ribs \& stomach. Inhale through nose, expand ribs (not shoulders). Exhale, draw navel to spine, engage core. Core Strengthening Abdominal Bracing: Tighten abs, hold while breathing. Pelvic Tilt: Flatten lower back, lift tailbone slightly. Hold 5-10s. Dead Bug: Lower opposite arm \& leg, return. Alternate. Quadruped (Bird Dog): On all fours, extend opposite arm \& leg. Hold 2-3s. Plank: Forearms down, straight body. Hold 20-60s. Bridge: Lift hips, squeeze glutes, lower slowly. Segmental Rolling: Roll with upper body first, then lower body. Swiss Ball Marching: Sit tall, lift one foot at a time. | Other | core strengthening with pilate breathing |
Primary outcome
pulmonary Function
Time frame: 6 weeks
Pulmonary function will be assessed using spirometry following standard ATS/ERS procedures. Key parameters recorded will include FVC, FEV₁, and the FEV₁/FVC ratio. Spirometry will be used to evaluate baseline respiratory status and monitor any changes over time.
Functional capacity
Time frame: 6 weeks
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk at their usual pace for six minutes along a standardized, measured corridor. The total distance walked (in meters) will be recorded as the outcome. Standardized encouragement and safety monitoring will be followed according to established guidelines.
Blood sugar levels
Time frame: 6 weeks
Blood sugar level will be measured using a calibrated glucometer. A capillary blood sample will be obtained via finger-prick, and glucose concentration will be recorded in mg/dL according to standard operating procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Strengthening with Diaphragmatic Breathing and core strengthening with pilate breathing in people with Diabetes Type II, run by Foundation University Islamabad 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kinza Maqbool, DPT (03077493722, kinzamaqbool88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary Function (time frame: 6 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 18 Dec 2025.