Chronic Obstructive Pulmonary DiseaseNCT06530043
Comparing Senobi and Jacobsons Exercises in COPD
A study testing Senobi exercises and Jacobsons Muscular relaxation exercises in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to evaluate the effects of Senobi versus Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in chronic obstructive pulmonary disease. The study design will be a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Senobi exercises and Jacobsons Muscular relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jul 2024to 25 Oct 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age 35-50 years
- Diagnosed COPD patients of stage 2-3 according to gold criteria (moderate)
Who cannot join
- Patients with neurological disorders
- History of fractures (68)
- History of other pulmonary complications
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
Samia Sarmad, PHD, 03004813195, info@hospital.uol.edu.pk
Jawad, 03124047465, info@hospital.uol.edu.pk
About this study
Official title: Effects of Senobi Exercises Versus Jacobsons Muscular Relaxation Exercises on Pulmonary Functions, Dyspnea, and Sleep Quality in Chronic Obstructive Pulmonary Disease
The study aims to evaluate the effects of Senobi versus Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in chronic obstructive pulmonary disease. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS and AHS. A non-probability convenient sampling technique will be used to recruit the individuals into two groups. Group A had undergone Senobi exercises and Group B engaged in Jacobsons Muscular relaxation exercises along with conventional treatment of COPD.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Senobi exercises, Jacobsons Muscular relaxation exercises
- Keywords
- Jacobsons Muscular relaxation exercises, Senobi exercises
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senobi exercisesOther
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.
Jacobsons Muscular relaxation exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Senobi exercises | Experimental | * Group A had undergone Senobi exercises training, scheduled three times weekly over 8 weeks, for individuals with COPD the duration and time interval time for Senobi exercises can vary depending on their overall health, fitness level, and tolerance.
* The session 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.
* In the second step exhale slowly through the mouth, emptying the lungs for a count of 4-5 seconds, and hold the breath for 2-3 seconds.
* The session started with a shorter session (3-5 minutes) and increased gradually as participants built up endurance with a breathing rate of 4-6 breaths per minute.
* The cycle of Senobi exercises was repeated for 5-10 minutes and 2-3 times a day. Receives: Other: Senobi exercises |
| Jacobsons Muscular relaxation exercises | Experimental | * Group B engaged in a Jacobsons Muscular relaxation exercises plan, following the same frequency and duration as the Senobi exercise program-three sessions per week for 8 weeks.
* The session 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.
* Repeat the cycle 2-3 times per day with deep breaths between each cycle.
* The session started with a shorter session (3-5 minutes) and increased gradually as participants built up endurance with a breathing rate of 4-6 breaths per minute. Receives: Other: Jacobsons Muscular relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1(Forced Expiratory Volume per second)
Pulmonary Function Test using Digital Spirometer
Measured: Pre and Post after 6 week
FVC(Forced Vital Capacity)
Pulmonary Function Test using Digital Spirometer
Measured: Pre and Post after 6 week
Modified Borg dyspnea Scale
To asses dyspnea
Measured: Pre and Post after 6 week
6-minutes walk Test
To asses dyspnea
Measured: Pre and Post after 6 week
SATED SLEEP questionnaire
To asses sleep
Measured: Pre and Post after 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start25 Jul 2024
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- 40 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
- NCT06530043
- Sponsor's protocol ID
- REC/RCR & AHS/23/0374
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Senobi Exercises Versus Jacobsons Muscular Relaxation Exercises on Pulmonary Functions, Dyspnea, and Sleep Quality in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06530043
- Acronym / sponsor ID
- REC/RCR & AHS/23/0374
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Jacobsons Muscular relaxation exercises, Senobi exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 31 Jul 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.
The study aims to evaluate the effects of Senobi versus Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in chronic obstructive pulmonary disease. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS and AHS. A non-probability convenient sampling technique will be used to recruit the individuals into two groups. Group A had undergone Senobi exercises and Group B engaged in Jacobsons Muscular relaxation exercises along with conventional treatment of COPD.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senobi exercises | Experimental | Other: Senobi exercises* Group A had undergone Senobi exercises training, scheduled three times weekly over 8 weeks, for individuals with COPD the duration and time interval time for Senobi exercises can vary depending on their overall health, fitness level, and tolerance. * The session 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. * In the second step exhale slowly through the mouth, emptying the lungs for a count of 4-5 seconds, and hold the breath for 2-3 seconds. * The session started with a shorter session (3-5 minutes) and increased gradually as participants built up endurance with a breathing rate of 4-6 breaths per minute. * The cycle of Senobi exercises was repeated for 5-10 minutes and 2-3 times a day. |
| Jacobsons Muscular relaxation exercises | Experimental | Other: Jacobsons Muscular relaxation exercises* Group B engaged in a Jacobsons Muscular relaxation exercises plan, following the same frequency and duration as the Senobi exercise program-three sessions per week for 8 weeks. * The session 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. * Repeat the cycle 2-3 times per day with deep breaths between each cycle. * The session started with a shorter session (3-5 minutes) and increased gradually as participants built up endurance with a breathing rate of 4-6 breaths per minute. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders
- Age 35-50 years
- Diagnosed COPD patients of stage 2-3 according to gold criteria (moderate)
Key exclusion criteria (3 listed)
- Patients with neurological disorders
- History of fractures (68)
- History of other pulmonary complications
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 |
|---|---|---|
| Senobi exercisesSenobi 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. | Other | Senobi exercises |
| Jacobsons Muscular relaxation exercisesJacobsons 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. | Other | Jacobsons Muscular relaxation exercises |
Primary outcome
FEV1(Forced Expiratory Volume per second)
Time frame: Pre and Post after 6 week
Pulmonary Function Test using Digital Spirometer
FVC(Forced Vital Capacity)
Time frame: Pre and Post after 6 week
Pulmonary Function Test using Digital Spirometer
Modified Borg dyspnea Scale
Time frame: Pre and Post after 6 week
To asses dyspnea
6-minutes walk Test
Time frame: Pre and Post after 6 week
To asses dyspnea
SATED SLEEP questionnaire
Time frame: Pre and Post after 6 week
To asses sleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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. 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 Senobi exercises and Jacobsons Muscular relaxation exercises in people with Chronic Obstructive Pulmonary Disease, 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 3 inclusion and 3 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 31 Jul 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 Talha Bilal, DPT (03317091847, talhakhan7747@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1(Forced Expiratory Volume per second) (time frame: Pre and Post after 6 week). The study lists 5 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 31 Jul 2024.