- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543551
Effects of Diagrammatic Breathing With and Without Resistance in Post Covid Patients on ADLs
Effects of Diaphragmatic Breathing With and Without Resistance Program on Functional Capacity and Activity of Daily Living in Post Covid Patients.
Study Overview
Status
Conditions
Detailed Description
The pandemic caused by the spread of the COVID-19 virus has implied a major challenge for the health systems and economies all around the world, as well as for their justice institutions; After COVID recovery subject feels muscle weakness and joint stiffness; extreme tiredness (fatigue) and a lack of energy; sleep problems. And these factors disturb the individuals daily activities of life like unable do household chores and social activities. Breathing is a natural process that usually occurs without conscious effort. However, the average breath tends be shallow and does not engage the diaphragm very much. During diaphragmatic breathing, a person consciously engages their diaphragm in order take deeper breaths. A person will notice their stomach rising and falling. They will also feel an expanding or stretching sensation in the stomach, rather than solely in their chest and shoulders. In this research determine the effects of diaphragmatic breathing with and without resistance exercise program on functional capacity and activity of daily living in post COVID patients.
This study will be a randomized controlled trial. This study will be conducted in general hospital Lahore. In the present study under considerations we mainly look on the subjects meeting predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Sample size will be 42 including both male and female. QUESTIONNAIRE used as subjective measurements and BARTHEL INDEX as objective measurement. PCFS will be used to check the functional capacity and ordinal scale used to measure performance in activities of daily living will be used check activity of daily living. Subjects of one group will be treated with resistance training at both limbs, at upper limb wall press-up and dumbbell biceps curls will be used but at lower limb back squats and leg press will be used and the other group will be treated without resistance training. Each group performed special trainings for 12 weeks, 2 sessions per week; each session took about 1 hour. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of the protocol. Post treatment reading of PCFS and Barthel quality of life will be recorded after every week. Outcome variables will be PCFS, ordinal scale used to measure performance in activities of daily living and pulse oximeter. Data will be analyzed on SPSS-25.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 042
- Iettefaq hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed patients of COVID-19
- patients having age 30 to 60 years of both male and female
- patients who have distributed ADLs due to COVID
- Absence of fever and improvement in respiratory symptoms
- patients who will be willing to participants in the study
Exclusion Criteria:
- any malignant or chronic diseases
- pregnant or lactating women
- poor quality CMR(cardiac magnetic resonance)post recovery
- patients having less than 20 and greater than 60
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 |
|---|---|
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Experimental: Diaphragmatic breathing with Resistance Training
Diaphragmatic breathing with Resistance Training: Wall press-up: Attempt 3 sets of 5 to 10 repetitions. Dumbbell biceps curls: Attempt 3 sets of 5 to 10 repetitions. Back squats: 1 set of 10 repetitions Leg press:1 set of 10 repetitions |
Wall press-up: Stand arm's length from the wall. Place your hands flat against the wall at chest level, with your fingers pointing upwards. With your back straight, slowly bend your arms, keeping your elbows by your side. Dumbbell biceps curls: Hold a pair of light weights and stand with your feet hip-width. Keeping your arms by your side, slowly bend them until the weight in your hand reaches your shoulder. Slowly lower again. Back squats: Place barbell with weights onto the squat rack. Bring your body under the bar. Rest barbell over your traps and shoulders. Make sure hands are even on each side of the bar. Keep your feet in the same position as they would be for an air squat. Brace your midline and keep your chest up. Leg press: Position feet about shoulder width apart. Try to push through your heels, keeping the knees lined up over the toes. Extend the legs until nearly straight, avoiding locking the knees. |
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Active Comparator: Diaphragmatic breathing exercises without Resistance Training
Diaphragmatic Breathing:
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Diaphragmatic Breathing:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post Covid Functional Status (PCFS):
Time Frame: 8 weeks
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A questionnaire covering the entire range of functional limitations, including changes in lifestyle, sports, and social activities.
It was graded as Grade 0, if there was a negligible effect on activities for patients was considered Grade 1, whereas a lower intensity of the activities was considered as Grade 2. Grade 3 accounted for the inability to perform certain accomplishments, forcing patients to structurally modify these.
Finally, Grade 4 was reserved for those patients with unembellished functional restrictions.
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8 weeks
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Barthel Index for Activity of daily living
Time Frame: 8 weeks
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The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.
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8 weeks
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Pulse Oximetry
Time Frame: 8 weeks
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Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sumera abdulhameed, ms, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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/0331 Ushma Zulifqar
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
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