NCT07290231

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

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

August 6, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

September 11, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

core strengthening exercisesPilate breathing exercisesdiaphragmatic breathing exercisesType II Diabetes

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 weeks

Study Arms (2)

core strengthening with diaphragmatic breathing

EXPERIMENTAL

detailed components of core strengthening exercises and diaphragmatic breathing

Other: Core Strengthening with Diaphragmatic Breathing

core strengthening with pilate breathing

EXPERIMENTAL

detailed components of core strengthening exercises and pilate breathing

Other: core strengthening with pilate breathing

Interventions

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 diaphragmatic breathing

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.

core strengthening with pilate breathing

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy, Islamabad, 44000

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

kinza Maqbool, DPT

CONTACT

sana Bashir, MS-CPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be kept blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

December 18, 2025

Study Start

August 6, 2025

Primary Completion

January 3, 2026

Study Completion

February 10, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations