COVID-19 PandemicNCT05543551
Effects of Diagrammatic Breathing With and Without Resistance in Post Covid Patients on ADLs
A study testing Diaphragmatic breathing with Resistance Training and diaphragmatic breathing with out resistance training in people with COVID-19 Pandemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
Effects of diaphragmatic breathing exercise with and without resistance exercise program on functional capacity and activity of daily living in post covid patients Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Diaphragmatic breathing with Resistance Training and diaphragmatic breathing with out resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Sep 2022to 10 Dec 2022
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diaphragmatic Breathing With and Without Resistance Program on Functional Capacity and Activity of Daily Living in Post Covid Patients.
Effects of diaphragmatic breathing exercise with and without resistance exercise program on functional capacity and activity of daily living in post covid patients
Read the 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.
- Conditions
- COVID-19 Pandemic
- Being tested
- Diaphragmatic breathing with Resistance Training, diaphragmatic breathing with out resistance training
- Keywords
- : COVID, Exercise training, Functional Capacity.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing with Resistance TrainingOther
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.
diaphragmatic breathing with out resistance trainingOther
Diaphragmatic Breathing:
- Lie on your back on a flat surface (or in bed) with your knees bent. You can use a pillow under your head and your knees for support if that's more comfortable.
- Place one hand on your upper chest and the other on your belly, just below your rib cage.
- Breathe in slowly through your nose, letting the air in deeply, towards your lower belly. The hand on your chest should remain still, while the one on your belly should rise.
- Tighten your abdominal muscles and let them fall inward as you exhale through pursed lips. The hand on your belly should move down to its original position. You can also practice this sitting in a chair, with your knees bent and your shoulders, head, and neck relaxed
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing with Resistance Training | Experimental | 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 Receives: Other: Diaphragmatic breathing with Resistance Training |
| Diaphragmatic breathing exercises without Resistance Training | Active comparator | Diaphragmatic Breathing:
1. Lie on your back on a flat surface (or in bed) with your knees bent. You can use a pillow under your head and your knees for support if that's more comfortable.
2. Place one hand on your upper chest and the other on your belly, just below your rib cage.
3. Breathe in slowly through your nose, letting the air in deeply, towards your lower belly. The hand on your chest should remain still, while the one on your belly should rise.
4. Tighten your abdominal muscles and let them fall inward as you exhale through pursed lips. The hand on your belly should move down to its original position. You can also practice this sitting in a chair, with your knees bent and your shoulders, head, and neck relaxed Receives: Other: diaphragmatic breathing with out resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Covid Functional Status (PCFS):
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.
Measured: 8 weeks
Barthel Index for Activity of daily living
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.
Measured: 8 weeks
Pulse Oximetry
Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start2 Sep 2022
- Primary completion1 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sumera abdulhameed, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543551
- Sponsor's protocol ID
- REC/0331 Ushma Zulifqar
- Status last verified
- Jul 2023
- First submitted
- 15 Sep 2022
- Last updated
- 25 Jul 2023
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic Breathing With and Without Resistance Program on Functional Capacity and Activity of Daily Living in Post Covid Patients.
- ClinicalTrials.gov ID
- NCT05543551
- Acronym / sponsor ID
- REC/0331 Ushma Zulifqar
- Conditions
- COVID-19 Pandemic
- Keywords
- : COVID, Exercise training, Functional Capacity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 16 Sep 2022 (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.
Effects of diaphragmatic breathing exercise with and without resistance exercise program on functional capacity and activity of daily living in post covid patients
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing with Resistance Training | Experimental | Other: Diaphragmatic breathing with Resistance TrainingDiaphragmatic 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 |
| Diaphragmatic breathing exercises without Resistance Training | Active comparator | Other: diaphragmatic breathing with out resistance trainingDiaphragmatic Breathing: 1. Lie on your back on a flat surface (or in bed) with your knees bent. You can use a pillow under your head and your knees for support if that's more comfortable. 2. Place one hand on your upper chest and the other on your belly, just below your rib cage. 3. Breathe in slowly through your nose, letting the air in deeply, towards your lower belly. The hand on your chest should remain still, while the one on your belly should rise. 4. Tighten your abdominal muscles and let them fall inward as you exhale through pursed lips. The hand on your belly should move down to its original position. You can also practice this sitting in a chair, with your knees bent and your shoulders, head, and neck relaxed |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Diaphragmatic breathing with Resistance TrainingWall 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. | Other | Diaphragmatic breathing with Resistance Training |
| diaphragmatic breathing with out resistance trainingDiaphragmatic Breathing: 1. Lie on your back on a flat surface (or in bed) with your knees bent. You can use a pillow under your head and your knees for support if that's more comfortable. 2. Place one hand on your upper chest and the other on your belly, just below your rib cage. 3. Breathe in slowly through your nose, letting the air in deeply, towards your lower belly. The hand on your chest should remain still, while the one on your belly should rise. 4. Tighten your abdominal muscles and let them fall inward as you exhale through pursed lips. The hand on your belly should move down to its original position. You can also practice this sitting in a chair, with your knees bent and your shoulders, head, and neck relaxed | Other | Diaphragmatic breathing exercises without Resistance Training |
Primary outcome
Post Covid Functional Status (PCFS):
Time frame: 8 weeks
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.
Barthel Index for Activity of daily living
Time frame: 8 weeks
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.
Pulse Oximetry
Time frame: 8 weeks
Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- 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.
sumera abdulhameed, MS 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 Diaphragmatic breathing with Resistance Training and diaphragmatic breathing with out resistance training in people with COVID-19 Pandemic, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Covid Functional Status (PCFS): (time frame: 8 weeks). The study lists 3 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 25 Jul 2023.