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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Inspiratory Muscle training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sheikh Zayed Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

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.

Outcomes

Primary Outcome Measures

Six-minute walk test (6MWT) Distance
Six-minute walk test (6MWT) was applied in a 30-m unobstructed corridor. Patients and controls were instructed to walk at their own pace but to cover as much meter as possible within 6 min. Each minute standardized encouragement was given to the patients. Patients were allowed to stop and rest during the test but were instructed to go on walking as soon as they were able to do so. Heart rate and spo2 were monitored using pulse oximetry before and ending the test. Maximum heart rate values achieved during the tests were recorded. The rate of the perceived exertional scale was used before and after the 6MWT. The 6MWT distance is expressed as a percentage of the predicted values.
Pulmonary function test.
Measurements of forced vital capacity and forced expiratory volume in 1, forced expiratory volume in one second/forced vital capacity, peak expiratory pressure was obtained with a computerized spiro-lab device as recommended by the European respiratory society, and results were expressed as a percentage of predicted values.
SF-36
Quality of life was assessed using SF-36. The SF-36 is a generic measure, consisting of eight subscales and 36 items. These subscales are physical functioning, role-physical, role- emotional, mental health, social functioning, bodily pain, general health. All subscales range from 0 (worst possible) to100 points (best health).

Secondary Outcome Measures

Full Information

First Posted
August 5, 2021
Last Updated
August 11, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05005702
Brief Title
Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure.
Official Title
Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-minute walk test (6MWT) Distance
Description
Six-minute walk test (6MWT) was applied in a 30-m unobstructed corridor. Patients and controls were instructed to walk at their own pace but to cover as much meter as possible within 6 min. Each minute standardized encouragement was given to the patients. Patients were allowed to stop and rest during the test but were instructed to go on walking as soon as they were able to do so. Heart rate and spo2 were monitored using pulse oximetry before and ending the test. Maximum heart rate values achieved during the tests were recorded. The rate of the perceived exertional scale was used before and after the 6MWT. The 6MWT distance is expressed as a percentage of the predicted values.
Time Frame
6 week
Title
Pulmonary function test.
Description
Measurements of forced vital capacity and forced expiratory volume in 1, forced expiratory volume in one second/forced vital capacity, peak expiratory pressure was obtained with a computerized spiro-lab device as recommended by the European respiratory society, and results were expressed as a percentage of predicted values.
Time Frame
6 week
Title
SF-36
Description
Quality of life was assessed using SF-36. The SF-36 is a generic measure, consisting of eight subscales and 36 items. These subscales are physical functioning, role-physical, role- emotional, mental health, social functioning, bodily pain, general health. All subscales range from 0 (worst possible) to100 points (best health).
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults 40-60 years old who are sedentary. Left ventricular ejection fraction of less than 45% evaluated by echocardiogram Functional class II and III (New York Heart Association) FEV1 less than 80%, predicted and/or FEV1/ forced vital capacity (FVC) ratio of more than 70% predicted, and clinical stability. Ex-smokers of more than 5 years. Exclusion Criteria: Myocardial infarction Complex arrhythmias Uncontrolled hypertension Angina pectoris. Cognitive disorders Recent any trauma. Chronic respiratory disease. Unstable angina Recent viral infections (6 months before the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheikh Zayed Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure.

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