Clinical trial NCT06530043: Comparing Senobi and Jacobsons Exercises in COPD
Official title: Effects of Senobi Exercises Versus Jacobsons Muscular Relaxation Exercises on Pulmonary Functions, Dyspnea, and Sleep Quality in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Jacobsons Muscular relaxation exercises, Senobi exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1(Forced Expiratory Volume per second)
timeFrame: Pre and Post after 6 week
measure: FVC(Forced Vital Capacity)
timeFrame: Pre and Post after 6 week
measure: Modified Borg dyspnea Scale
timeFrame: Pre and Post after 6 week
measure: 6-minutes walk Test
timeFrame: Pre and Post after 6 week
measure: SATED SLEEP questionnaire
timeFrame: Pre and Post after 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tasneem Shehzadi, Mphil
role: PRINCIPAL_INVESTIGATOR
References: