NCT06530043

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

July 25, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 28, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

Jacobsons Muscular relaxation exercises, Senobi exercises

Outcome Measures

Primary Outcomes (5)

  • FEV1(Forced Expiratory Volume per second)

    Pulmonary Function Test using Digital Spirometer

    Pre and Post after 6 week

  • FVC(Forced Vital Capacity)

    Pulmonary Function Test using Digital Spirometer

    Pre and Post after 6 week

  • Modified Borg dyspnea Scale

    To asses dyspnea

    Pre and Post after 6 week

  • 6-minutes walk Test

    To asses dyspnea

    Pre and Post after 6 week

  • SATED SLEEP questionnaire

    To asses sleep

    Pre and Post after 6 week

Study Arms (2)

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.

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.

Other: Jacobsons Muscular relaxation exercises

Interventions

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.

Senobi 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.

Jacobsons Muscular relaxation exercises

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Age 35-50 years
  • Diagnosed COPD patients of stage 2-3 according to gold criteria (moderate)

You may not qualify if:

  • Patients with neurological disorders
  • History of fractures (68)
  • History of other pulmonary complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tasneem Shehzadi, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Talha Bilal, DPT

CONTACT

Tasneem Shahzadi, TDPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

July 25, 2024

Primary Completion

September 25, 2024

Study Completion

October 25, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations