- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530043
Comparing Senobi and Jacobsons Exercises in COPD
Effects of Senobi Exercises Versus Jacobsons Muscular Relaxation Exercises on Pulmonary Functions, Dyspnea, and Sleep Quality in Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It will be a randomized clinical trial with 40 participants, aimed to compare the effects of Senobi and Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in COPD patients. Participants were chosen through convenient sampling at Sarwet Anver Medical Complex Lahore. Participants were divided into Groups A and B. Group A had undergone Senobi exercises and Group B had engaged in Jacobsons muscular relaxation exercises. The pulmonary function was assessed by spirometer the calculated values will be FVC (Forced vital capacity) and FEV1(Forced expiratory volume in one second). The dyspnea will be assessed by a 6-minute walk test and at the end of the walk state of breathlessness will be evaluated by the Modified Borg Dyspnea Scale. The sleep quality will be assessed by the SATED sleep questionnaire The exercises were evaluated after 6 weeks of interventions. Data was analyzed using SPSS software version 2.5.
Spirometry assesses the amount and speed of air that can be inhaled and exhaled. Key measurements include Forced Vital Capacity (FVC). The maximum volume of air forcefully exhaled after a full inhalation. Forced Expiratory Volume in 1 second (FEV1): The volume of air exhaled in the first second of the FVC test, indicates how quickly the lungs can be emptied.
The modified Borg dyspnea score is a variation of the CR10 scale, with a range from 0 to 10, where 0 signifies the absence of breathlessness and 10 indicates the highest level of breathlessness. Participants assess their dyspnea after the 6-minute walk distance (6MWD) test, capturing the peak intensity of breathlessness experienced throughout the entire walking test. This scoring system provides a subjective measure of the individual's maximal perceived dyspnea during physical activity.
The SATED scale includes specific quantitative criteria for four of the five sleep-related dimensions that have been reliably linked to health outcomes. It evaluates five important aspects of sleep. These include the following dimensions: sleep satisfaction, sleep efficiency, sleep duration, timing of sleep, and alertness during waking hours.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Talha Bilal, DPT
- Phone Number: 03317091847
- Email: talhakhan7747@gmail.com
Study Contact Backup
- Name: Tasneem Shahzadi, TDPT
- Phone Number: 03104108327
- Email: Tasneem.shehzadi@ripha.edu.pk
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- University of Lahore Teaching Hospital
-
Contact:
- Samia Sarmad, PHD
- Phone Number: 03004813195
- Email: info@hospital.uol.edu.pk
-
Contact:
- Jawad
- Phone Number: 03124047465
- Email: info@hospital.uol.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Both genders
- Age 35-50 years
- Diagnosed COPD patients of stage 2-3 according to gold criteria (moderate)
Exclusion Criteria:
- Patients with neurological disorders
- History of fractures (68)
- History of other pulmonary complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Senobi exercises
|
Senobi exercise began with the comfortable sitting of participants with slow inhalation, filling the lungs for a count of 4-5 seconds and holding the breath for 2-3 seconds.
|
|
Experimental: Jacobsons Muscular relaxation exercises
|
Jacobsons Muscular relaxation exercises started by tensing the muscles in the toes and then moving up the body tensing and relaxing each muscle group in turn (feet and toes, calves, thighs, hips, lower back, upper back, shoulders, arms, hands, neck, and head) and hold it for 5-7 seconds and released it for 5-7 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1(Forced Expiratory Volume per second)
Time Frame: Pre and Post after 6 week
|
Pulmonary Function Test using Digital Spirometer
|
Pre and Post after 6 week
|
|
FVC(Forced Vital Capacity)
Time Frame: Pre and Post after 6 week
|
Pulmonary Function Test using Digital Spirometer
|
Pre and Post after 6 week
|
|
Modified Borg dyspnea Scale
Time Frame: Pre and Post after 6 week
|
To asses dyspnea
|
Pre and Post after 6 week
|
|
6-minutes walk Test
Time Frame: Pre and Post after 6 week
|
To asses dyspnea
|
Pre and Post after 6 week
|
|
SATED SLEEP questionnaire
Time Frame: Pre and Post after 6 week
|
To asses sleep
|
Pre and Post after 6 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tasneem Shehzadi, Mphil, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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