NCT07325942

Brief Summary

this study aims to investigate the effect of low vs high volume- high intensity interval training on functional capacity and quality of life in chronic heart failure patients

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

December 9, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 9, 2025

Last Update Submit

January 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 6 minute walk test

    self-paced submaximal field exercise test to assess submaximal functional capacity of the patient , the distance walked by the patient for six minutes will be measured by meters

    at enrolment and at the end of treatment at 8 weeks

  • 2D Echocardiographic parameters

    Left ventricle geometry: left ventricular end-diastolic diameter (LVEDD) mm, left ventricular end-systolic diameter (LVESD) mm, left ventricular end-systolic volume (LVESV) ml. and, left ventricular end-diastolic volume (LVEDV) ml. Left ventricle Systolic function: left ventricular ejection fraction (LVEF) % Left ventricle Diastolic function :E wave cm/s: early diastolic mitral inflow velocity, A wave cm/s: diastolic mitral inflow velocity during late atrial contraction , E/A ratio

    at enrollment and at the end of treatment at 8 weeks

Secondary Outcomes (1)

  • Minnesota living with heart failure questionnaire (MLHFQ)

    at enrollment and at the end of treatment at 8 weeks

Study Arms (3)

Low volume high intensity interval training

EXPERIMENTAL

This group will receive the usual care (standard medical treatment) in addition to LV-HIIT on a treadmill for 8 weeks, 2 sessions per week.

Other: low-volume high intensity interval trainingDrug: Standard medical treatment

high volume high intensity interval training

EXPERIMENTAL

In this group, the patients will receive the usual care (standard treatment) in addition to HV-HIIT on a treadmill for 8 weeks, 2 sessions per week

Other: High volume high intensity interval trainingDrug: Standard medical treatment

control group

OTHER

It includes 15 patients who will receive standard medical treatment only

Drug: Standard medical treatment

Interventions

Low-volume HIIT (LV-HIIT) is a particularly time-efficient subtype of interval training, which has gained increasing attention in recent years. As per the previous definition, these brief training protocols typically involve≤10 min of intense exercise within a session lasting≤30 min including warm-up, recovery phases between intervals, and cool-down

Low volume high intensity interval training

long (2-4 min) bouts of high (not maximum) intensity exercise interspersed with recovery periods which have wide varieties in the protocols according to the intensity, duration, and number of intervals performed

high volume high intensity interval training

standard medical treatment for chronic heart failure as per international guidlines

Low volume high intensity interval trainingcontrol grouphigh volume high intensity interval training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stable heart failure patient with reduced ejection fraction (EF \<40)
  • Age Above 18 years old
  • Both males and females
  • The ability to provide informed consent

You may not qualify if:

  • Based on the Scientific Statement from the American Heart Association: contraindications for exercise Testing and Training. (Fletcher et al., 2013)
  • Acute myocardial infarction (MI), within 2 days
  • Ongoing unstable angina
  • Uncontrolled cardiac tachy or brady arrhythmia with hemodynamic compromise
  • Active endocarditis
  • Symptomatic severe aortic stenosis
  • Decompensated heart failure
  • Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
  • Acute myocarditis or pericarditis
  • Acute aortic dissection
  • Physical disability that precludes safe and adequate testing or training
  • Known obstructive left main coronary artery stenosis
  • Hypertrophic obstructive cardiomyopathy with severe resting gradient
  • Recent stroke or transient ischemic attack
  • Mental impairment with limited ability to cooperate
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapy specialist

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 8, 2026

Study Start

December 10, 2025

Primary Completion (Estimated)

June 6, 2026

Study Completion (Estimated)

June 6, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations