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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: HIITS; Other: MICT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 0000
    • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

  1. Signs of acute heart failure, unstable angina or severe arrhythmia three months prior to enrolment in the study.
  2. Pacemakers.
  3. Chronic obstructive pulmonary disease.
  4. Other disorders counteracting exercise testing conditions that limit lower limb mobility (for example, burns, fractures)
  5. Pre-existing neuromuscular diseases (for example Myasthenia Gravis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; high intensity interval training	Other: HIITS; 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
Experimental: group B; moderate intensity continuous training	Other: MICT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soluble ST2 biomarker level	sample was taken at the cubited vein at the beginning of the program and also at its end	before the start of the trail and at the end of the trail 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ejection fraction	Left ventricular systolic dysfunction was assessed using the ejection fraction by 2D simpson method	before the start of the trail and at the end of the trail 3 months
mannisota of daily living questionnaire score	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.	before the start of the trail and at the end of the trail 3 months
peak exercise response	monitoring the peak exercise response	before the start of the trail and at the end of the trail 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Donia M Elmasry, Doctorate, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: sST2 biomarker; Minnesota Questionare; HIITS
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P.T.REC/012/004017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol and final results
• IPD Sharing Time Frame: August 2024 till December 2024
• IPD Sharing Access Criteria: researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No