Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure.

NCT ID: NCT05005702

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2021-07-15

Brief Summary

Heart failure is a complex clinical syndrome manifesting as inability to supply adequate blood flow throughout the body due to any structural or functional cardiac abnormality. The most common complaints are exercise intolerance, balance, dyspnea, and fatigue in patients with heart failure. It is clearly stated that pulmonary muscle weakness is prevalent and contributes to exercise intolerance in patients with heart failure. Purpose of the study was to evaluate the efficacy of inspiratory muscle traning on pulmonary muscle strength, pulmonary function test, functional capacity and quality of life. The tools used were 6-minute walk test, spirometry, IMT threshold device for IMT strength, and Quality of life. Study was conducted in 20 patients in single group and pre and post values were evaluated. The significance this study bears was that it helped defining for us that to how much extent we can improve the physical and pulmonary functional capacity using inspiratory muscle training. Data were analysed using spss 22.0.mean and standard deviation were calculated. Appropirate the stasitical test were used after checking normailty of data. Parametric test were used for data analysis using SPSS 22

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

Patients were assigned to inspiratory muscle training (IMT) for 6 weeks. During training, patients were instructed to maintain diaphragmatic breathing, and try to maintain 10-15 breaths, and rested 5-10 between breaths. As soon as the patients managed; they were encouraged to maintain 25-30 breaths at each workload. All patients wore nose-clip during training. The inspiratory load was set at 40% of maximal inspiratory pressure. The training session was supervised at the hospital.

Group Type: EXPERIMENTAL

Inspiratory Muscle training

Intervention Type: OTHER

Patients received IMT for 30-minute per day, 3 days per week for 3 weeks using the Threshold Inspiratory Muscle training device (product Phillips). During training, patients were instructed to maintain diaphragmatic breathing, and try to maintain 10-15 breaths, and rested 5-10 between breaths. As soon as the patients managed; they were encouraged to maintain 25-30 breaths at each workload. All patients wore nose-clip during training.

Inspiratory muscle training diaries were checked weekly. The inspiratory load was set at 40%of maximal inspiratory pressure.

Interventions

Inspiratory Muscle training

Patients received IMT for 30-minute per day, 3 days per week for 3 weeks using the Threshold Inspiratory Muscle training device (product Phillips). During training, patients were instructed to maintain diaphragmatic breathing, and try to maintain 10-15 breaths, and rested 5-10 between breaths. As soon as the patients managed; they were encouraged to maintain 25-30 breaths at each workload. All patients wore nose-clip during training.

Inspiratory muscle training diaries were checked weekly. The inspiratory load was set at 40%of maximal inspiratory pressure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults 40-60 years old who are sedentary.

2. Left ventricular ejection fraction of less than 45% evaluated by echocardiogram

3. Functional class II and III (New York Heart Association)

4. FEV1 less than 80%, predicted and/or FEV1/ forced vital capacity (FVC) ratio of more than 70% predicted, and clinical stability.

5. Ex-smokers of more than 5 years.

Exclusion Criteria

1. Myocardial infarction

2. Complex arrhythmias

3. Uncontrolled hypertension

4. Angina pectoris.

5. Cognitive disorders

6. Recent any trauma.

7. Chronic respiratory disease.

8. Unstable angina

9. Recent viral infections (6 months before the study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fareeha Kausar, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Sheikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

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Other Identifiers

REC/Lhr/20/0301 Ayesha Fatima

Identifier Type: -

Identifier Source: org_study_id