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Completed

NCT Number: NCT06647667

High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure

This study was designed to compare between the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on soluble ST2 biomarkers among chronic heart failure patients, also measure the improvement in the quality of life with different modes of exercise and with of it is more benifitial for the heart failure patient

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy Cairo University

Giza, 0000, Egypt

About this study

The data concerned with the study including soluble ST2 biomarker levels, ejection fraction and MLHFQ was measured before and after twelve weeks of treatment.In this study a total sixty male patients with chronic heart failure NYHA class (I &II) were selected from the outpatient clinic, El-Demerdash hospital, Ain-shams University. Their age ranged from 50-60 years. Patients were randomly assigned into two groups, group A receiving HIIT along with prescribed medical treatment and group B receiving MCT along with prescribed medical treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients selection was according to the following criteria:
  • Patients diagnosed with chronic heart failure (New York heart association class I& II) with systolic left ventricular dysfunction.
  • Their left ventricular ejection fraction (LVEF) <40%.
  • Medical treatment was optimized at least three months prior to study entry.
  • All patients didn't participate in any rehabilitation programs prior to the study.

Exclusion criteria

  • Patients who had met one of the following criteria were excluded from the study:
  • Signs of acute heart failure, unstable angina or severe arrhythmia three months prior to enrolment in the study.
  • Pacemakers.
  • Chronic obstructive pulmonary disease.
  • Other disorders counteracting exercise testing conditions that limit lower limb mobility (for example, burns, fractures)
  • Pre-existing neuromuscular diseases (for example Myasthenia Gravis).

Treatment and study plan

HIITS

Other

Frequency: HIIT will be in 2 supervised sessions per week for 12 weeks on the treadmill.

session duration from 30-40 min including the waming up and cooling down Intensity: HIIT included 4 minute intervals aiming 60-85% of heart rate reserve

MICT

Other

Frequency: Moderate continuous training is scheduled 2 times per week for 12 weeks.

Intensity: exercise had been applied on the treadmill with 40%-59% of heart rate reserve) session duration from 30-40 min including the warming up and cooling down

Primary outcomes

  1. soluble ST2 biomarker level

    Time frame: before the start of the trail and at the end of the trail 3 months

    sample was taken at the cubited vein at the beginning of the program and also at its end

Secondary outcomes

  1. ejection fraction

    Time frame: before the start of the trail and at the end of the trail 3 months

    Left ventricular systolic dysfunction was assessed using the ejection fraction by 2D simpson method

  2. mannisota of daily living questionnaire score

    Time frame: before the start of the trail and at the end of the trail 3 months

    The twenty one item questionnaire was usedfrom 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.

  3. peak exercise response

    Time frame: before the start of the trail and at the end of the trail 3 months

    monitoring the peak exercise response

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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