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

NCT06647667 | Completed DMC

• 1 other identifier: P.T.REC/012/004017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

sST2 biomarker; Minnesota Questionare; HIITS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ejection fraction

  before the start of the trail and at the end of the trail 3 months

• mannisota of daily living questionnaire score

  before the start of the trail and at the end of the trail 3 months

• peak exercise response

  before the start of the trail and at the end of the trail 3 months

Study Arms (2)

group A

EXPERIMENTAL

high intensity interval training

Other: HIITS

group B

EXPERIMENTAL

moderate intensity continuous training

Other: MICT

Interventions

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

group A

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

group B

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy Cairo University

Giza, 0000, Egypt

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Donia M Elmasry, Doctorate

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: 1. Patients will receive high intensity interval training (HIIT) 2. Patients will receive moderate intensity continuous training (MICT)

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: October 18, 2024
• Study Start: September 15, 2022
• Primary Completion: August 20, 2023
• Study Completion: October 16, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: August 2024 till December 2024
• Access Criteria: researchers

Locations

EG (1)