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High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High Intensity interval Training
Continuous Aerobic 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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with heart failure including both male and female Patients who can perform 6 MWT. According to classification of American heart association, class 1 heart failure patients are included. Exclusion Criteria: Heart failure patients along with orthopedic problems. Patients who have use pacemaker. Patient who have recent acute myocardial infraction or revascularization less than 3 months.

Sites / Locations

  • Poly clinic Hospital
  • Railway General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity interval Training

Continuous Aerobic training

Arm Description

Outcomes

Primary Outcome Measures

6MWT Distance
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min.
Minnesota living with heart failure questionnaire
MLWHFQ is commonly used health related quality of life questionnaires with heart failure. This is very easy to apply on patients and self-administered questionnaire. It has two components emotional and physical and total score. Each item is scored in a 6.likert scale (0 to 5), thus, the total score could range from 5 to 105, with higher scores indicating more significant impairment in health related quality of life. Changes from the basline will be measured
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Oxygen Saturation (SpO2)
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Modified Borg dyspnea scale
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2023
Last Updated
September 26, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05948371
Brief Title
High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
Official Title
Effects of High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

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
To determine the effect of high intensity aerobic interval training versus continuous aerobic training in heart failure patients.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity interval Training
Arm Type
Experimental
Arm Title
Continuous Aerobic training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High Intensity interval Training
Intervention Description
High Intensity interval Training Frequency: 3-5 day per week Intensity: 60 to 80% of HRR. If atrial fibrillation present use RPE of 11-14 on a 6-20 scale. Time: total 30 mint time.6 mint exercise with high intensity and 2 mints of low intensity for active recovery until 30 mints complete. Type: walking and static cycling. Walking Frequency 3 -5 days per week Intensity : use RPE of 11-14. Time:30 mint total. 6 mint walk with high intensity and 2 mint walk with low intensity until 30mints completed.
Intervention Type
Other
Intervention Name(s)
Continuous Aerobic training
Intervention Description
Continuous Aerobic training Frequency : 3-5 days per week. Intensity:40-70% of HHR. Time : initial 5-10 then 10-15 until 30mints without rest interval Type : walking and static cycling.
Primary Outcome Measure Information:
Title
6MWT Distance
Description
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min.
Time Frame
8 week
Title
Minnesota living with heart failure questionnaire
Description
MLWHFQ is commonly used health related quality of life questionnaires with heart failure. This is very easy to apply on patients and self-administered questionnaire. It has two components emotional and physical and total score. Each item is scored in a 6.likert scale (0 to 5), thus, the total score could range from 5 to 105, with higher scores indicating more significant impairment in health related quality of life. Changes from the basline will be measured
Time Frame
8 week
Title
Pulse Rate
Description
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Time Frame
8 week
Title
Oxygen Saturation (SpO2)
Description
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Time Frame
8 week
Title
Modified Borg dyspnea scale
Description
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Time Frame
8 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with heart failure including both male and female Patients who can perform 6 MWT. According to classification of American heart association, class 1 heart failure patients are included. Exclusion Criteria: Heart failure patients along with orthopedic problems. Patients who have use pacemaker. Patient who have recent acute myocardial infraction or revascularization less than 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Iqbal Tariq, PhD*
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poly clinic Hospital
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Hafiza Misbah Inayat
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Hafiza Misbah Inayat

12. IPD Sharing Statement

Plan to Share IPD
No

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High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.

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