Inspiratory Muscle TrainingNCT05063266
Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
A study testing Deep Breathing Exercise and Inspiratory muscle Training in people with Inspiratory Muscle Training, run by Riphah International University at 1 site in Pakistan.
Trial summary
Although the progressive nature of pulmonary hypertension (PH), including the impairment of respiratory muscle function, studies have demonstrated beneficial effects of physical exercise on the functional limitations caused by the disease in this population, being an important collaborator to the conventional drug… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Inspiratory Muscle Training
- What is being tested?
- Deep Breathing Exercise and Inspiratory muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Oct 2020to 15 Jul 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group of 40 to 70 years.
- Both male and females will be included.
- Patients with a diagnosis of PH (PAPm ≥ 25mmHg and PAOP <15mmHg);
- Clinically stable with augmented and unchanged daily medication therapy in the last three months; Subjects who agree to contribute in the research by signing a free and knowledgeable consent form.
Who cannot join
- COPD
- Severe ischemic heart disease
- Left heart failure;
- Cor pulmonale
- Cognitive disorders;
- Orthopedic problems; e.g;fracture in thoracic region.
- Emergency or elective surgical intervention during the protocol;
- Recent viral infections;
Trial locations and contacts
1 site in 1 country.
About this study
Although the progressive nature of pulmonary hypertension (PH), including the impairment of respiratory muscle function, studies have demonstrated beneficial effects of physical exercise on the functional limitations caused by the disease in this population, being an important collaborator to the conventional drug therapy.Respiratory muscle training (RMT) improves functional capacity and quality of life (QoL) in patients.A randomized controlled trial was conducted to evaluate the effectiveness of this protocol on respiratory muscle strength and endurance, functional capacity. 18 subjects were allocated in 2 groups, group A was control group and group B was experimental group. Group A or Control group received deep breathing exercises. Group B received 30 minutes of IMT 6days weekly for 2 weeks by using a pressure threshold device. The purpose of this study was to investigate the effects of inspiratory muscle training (IMT) in PAH. To evaluate effectiveness of IMT mouth pressure device ,functional capacity using 6 minute walking test (6MWT)health assessment via SF 36 questionnaire were used before and after training protocol.
- Conditions
- Inspiratory Muscle Training
- Being tested
- Deep Breathing Exercise, Inspiratory muscle Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Breathing ExerciseOther
control groups received deep breathing exercise 6 days a week for two weeks. Deep breathing exercises includes diaphragmatic breathing and pursed lip breathing.
Inspiratory muscle TrainingOther
Treatment group received inspiratory muscle training 20 minutes 6 days a week for two weeks.IMT was done by using pressure threshold device.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Deep Breathing exercise Receives: Other: Deep Breathing Exercise |
| Group B | Experimental | Inspiratory Muscle Training Receives: Other: Inspiratory muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min walk test (6 MWT)
The 6-min walk test (6 MWT) is a submaximal exercise test drive that includes measurement of distance walked throughout a period of 6 minutes. The 6-minute walk distance (6 MWD) stipulates a measure for collective global retort of multiple cardiopulmonary and musculoskeletal structures involved in workout.The 6 MWT provides information about functional capacity, response to rehabilitation and prognosis slanting a broad range of chronic cardiopulmonary situations. Main strengths of the 6 MWT curb from its simplicity in conception and performing, low cost, ease of consistency, and acceptance by test individuals, including those who are deconditioned, aged, or fragile.
Measured: 2nd week
SF 36
SF-36 is a setting of universal, clear, and easily instructed quality-of-life methods. These measures hang on upon patient self-reporting and are now widely utilized by trained care groups and by Medicare for everyday observing and assessment of care findings in mature patient role
Measured: 2nd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start13 Oct 2020
- Primary completion2 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inspiratory Muscle TrainingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha kausar, PP-DPT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063266
- Sponsor's protocol ID
- REC/0330 Shaherbano
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan P, Yuan XT, Sun XY, Pudasaini B, Liu JM, Hu QH. Exercise training for pulmonary hypertension: a systematic review and meta-analysis. Int J Cardiol. 2015 Jan 15;178:142-6. doi: 10.1016/j.ijcard.2014.10.161. Epub 2014 Oct 27. No abstract available.
PubMed 25464238Chia KS, Wong PK, Faux SG, McLachlan CS, Kotlyar E. The benefit of exercise training in pulmonary hypertension: a clinical review. Intern Med J. 2017 Apr;47(4):361-369. doi: 10.1111/imj.13159.
PubMed 27338855Becker-Grunig T, Klose H, Ehlken N, Lichtblau M, Nagel C, Fischer C, Gorenflo M, Tiede H, Schranz D, Hager A, Kaemmerer H, Miera O, Ulrich S, Speich R, Uiker S, Grunig E. Efficacy of exercise training in pulmonary arterial hypertension associated with congenital heart disease. Int J Cardiol. 2013 Sep 20;168(1):375-81. doi: 10.1016/j.ijcard.2012.09.036. Epub 2012 Oct 5.
PubMed 23041100Saglam M, Arikan H, Vardar-Yagli N, Calik-Kutukcu E, Inal-Ince D, Savci S, Akdogan A, Yokusoglu M, Kaya EB, Tokgozoglu L. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015 May-Jun;35(3):198-206. doi: 10.1097/HCR.0000000000000117.
PubMed 25909652Souza H, Rocha T, Pessoa M, Rattes C, Brandao D, Fregonezi G, Campos S, Aliverti A, Dornelas A. Effects of inspiratory muscle training in elderly women on respiratory muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci. 2014 Dec;69(12):1545-53. doi: 10.1093/gerona/glu182.
PubMed 25395284
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
- ClinicalTrials.gov ID
- NCT05063266
- Acronym / sponsor ID
- REC/0330 Shaherbano
- Conditions
- Inspiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 1 Oct 2021 (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.
Although the progressive nature of pulmonary hypertension (PH), including the impairment of respiratory muscle function, studies have demonstrated beneficial effects of physical exercise on the functional limitations caused by the disease in this population, being an important collaborator to the conventional drug therapy.Respiratory muscle training (RMT) improves functional capacity and quality of life (QoL) in patients.A randomized controlled trial was conducted to evaluate the effectiveness of this protocol on respiratory muscle strength and endurance, functional capacity. 18 subjects were allocated in 2 groups, group A was control group and group B was experimental group. Group A or Control group received deep breathing exercises. Group B received 30 minutes of IMT 6days weekly for 2 weeks by using a pressure threshold device. The purpose of this study was to investigate the effects of inspiratory muscle training (IMT) in PAH. To evaluate effectiveness of IMT mouth pressure device ,functional capacity using 6 minute walking test (6MWT)health assessment via SF 36 questionnaire were used before and after training protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Deep Breathing ExerciseDeep Breathing exercise |
| Group B | Experimental | Other: Inspiratory muscle TrainingInspiratory Muscle Training |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age group of 40 to 70 years.
- Both male and females will be included.
- Patients with a diagnosis of PH (PAPm ≥ 25mmHg and PAOP <15mmHg);
- Clinically stable with augmented and unchanged daily medication therapy in the last three months; Subjects who agree to contribute in the research by signing a free and knowledgeable consent form.
Key exclusion criteria (8 listed)
- COPD
- Severe ischemic heart disease
- Left heart failure;
- Cor pulmonale
- Cognitive disorders;
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 |
|---|---|---|
| Deep Breathing Exercisecontrol groups received deep breathing exercise 6 days a week for two weeks. Deep breathing exercises includes diaphragmatic breathing and pursed lip breathing. | Other | Group A |
| Inspiratory muscle TrainingTreatment group received inspiratory muscle training 20 minutes 6 days a week for two weeks.IMT was done by using pressure threshold device. | Other | Group B |
Primary outcome
6-min walk test (6 MWT)
Time frame: 2nd week
The 6-min walk test (6 MWT) is a submaximal exercise test drive that includes measurement of distance walked throughout a period of 6 minutes. The 6-minute walk distance (6 MWD) stipulates a measure for collective global retort of multiple cardiopulmonary and musculoskeletal structures involved in workout.The 6 MWT provides information about functional capacity, response to rehabilitation and prognosis slanting a broad range of chronic cardiopulmonary situations. Main strengths of the 6 MWT curb from its simplicity in conception and performing, low cost, ease of consistency, and acceptance by test individuals, including those who are deconditioned, aged, or fragile.
SF 36
Time frame: 2nd week
SF-36 is a setting of universal, clear, and easily instructed quality-of-life methods. These measures hang on upon patient self-reporting and are now widely utilized by trained care groups and by Medicare for everyday observing and assessment of care findings in mature patient role
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 1 Oct 2021.
- Background: PubMed 25464238Yuan P, Yuan XT, Sun XY, Pudasaini B, Liu JM, Hu QH. Exercise training for pulmonary hypertension: a systematic review and meta-analysis. Int J Cardiol. 2015 Jan 15;178:142-6. doi: 10.1016/j.ijcard.2014.10.161. Epub 2014 Oct 27. No abstract available.
- Background: PubMed 27338855Chia KS, Wong PK, Faux SG, McLachlan CS, Kotlyar E. The benefit of exercise training in pulmonary hypertension: a clinical review. Intern Med J. 2017 Apr;47(4):361-369. doi: 10.1111/imj.13159.
- Background: PubMed 23041100Becker-Grunig T, Klose H, Ehlken N, Lichtblau M, Nagel C, Fischer C, Gorenflo M, Tiede H, Schranz D, Hager A, Kaemmerer H, Miera O, Ulrich S, Speich R, Uiker S, Grunig E. Efficacy of exercise training in pulmonary arterial hypertension associated with congenital heart disease. Int J Cardiol. 2013 Sep 20;168(1):375-81. doi: 10.1016/j.ijcard.2012.09.036. Epub 2012 Oct 5.
- Background: PubMed 25909652Saglam M, Arikan H, Vardar-Yagli N, Calik-Kutukcu E, Inal-Ince D, Savci S, Akdogan A, Yokusoglu M, Kaya EB, Tokgozoglu L. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015 May-Jun;35(3):198-206. doi: 10.1097/HCR.0000000000000117.
- Background: PubMed 25395284Souza H, Rocha T, Pessoa M, Rattes C, Brandao D, Fregonezi G, Campos S, Aliverti A, Dornelas A. Effects of inspiratory muscle training in elderly women on respiratory muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci. 2014 Dec;69(12):1545-53. doi: 10.1093/gerona/glu182.
- Individual participant dataSharing planned: No
Related trials for Inspiratory Muscle Training
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
IMST for Dementia Risk Reduction
Systolic Blood Pressure, Blood Pressure
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Enrolling by invitation
Impact of Respiratory Muscle Training on Cognition in Older Adults
Older Adults
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.
Fareeha kausar, PP-DPT study chair
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 Deep Breathing Exercise and Inspiratory muscle Training in people with Inspiratory Muscle Training, 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 4 inclusion and 8 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 1 Oct 2021. 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?
6-min walk test (6 MWT) (time frame: 2nd week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063266, which also lists 5 linked publications.
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 1 Oct 2021.