NCT05948371

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

July 7, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    8 week

  • 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

    8 week

  • Pulse Rate

    Changes from baseline, Pulse rate was measured per minute through pulse oximeter

    8 week

  • 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.

    8 week

  • 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.

    8 week

Study Arms (2)

High Intensity interval Training

EXPERIMENTAL
Other: High Intensity interval Training

Continuous Aerobic training

ACTIVE COMPARATOR
Other: Continuous Aerobic training

Interventions

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.

High Intensity interval Training

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.

Continuous Aerobic training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Heart Failure

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 17, 2023

Study Start

September 1, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations