Effect of Aquatic High Intensity Resistive Training on Patients With Chronic Heart Failure

NCT06297707 | Recruiting DMC

• 1 other identifier: P.T.REC/012/005044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure. BACKGROUND: Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of \>37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Cardiac function

  echocardiogram Left ventricular systolic dysfunction will be assessed using the ejection fraction by 2D simpson method (the percentage of the end diastolic volume ejected during systole

  12 weeks

Secondary Outcomes (2)

• exercise capacity

  12 weeks

• physical symptoms of heart failure

  12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

aquatic high intensity resistive training

Other: aquatic high intensity resistive training

control group

ACTIVE COMPARATOR

usual care

Other: usual care

Interventions

aquatic high intensity resistive training OTHER

The experimental group participants will involve in aquatic high intensity resistive training sessions. The participants in the intervention group will receive 1 h of supervised lower limb aquatic resistance training three times a week for 12 weeks, for a total of 36 training sessions.

experimental group

usual care OTHER

The control group will maintain usual care and will be asked to continue their usual leisure time activities. They will be offered the possibility of participating in two sessions consisting of 1 h of light stretching and relaxation during the 3-month intervention period.

control group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranges from 45 to 60 years old. Have chronic heart failure (NYHA class I to III).
• Left ventricular ejection fraction (LVEF) \> 50%
• clinically stable with optimal pharmacological therapy in greater than three months
• All patients didn't participate in any rehabilitation programs prior to the study.

You may not qualify if:

• Signs of acute heart failure, unstable angina, or severe arrhythmia three months prior to enrolment in the study.
• Pacemakers. recently diagnosed acute coronary syndrome or a recent coronary intervention or both renal insufficiency (estimated glomerular filtration rate \< 30 mL/min) liver abnormalities uncontrolled hypertension moderate-to-severe valvular disease uncompensated heart failure patients Chronic lung disease. Other disorders counteracting exercise conditions that limit lower limb mobility (for example, burns, fractures)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Dokki, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• marwa elsayed

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa elsayed, PhD

CONTACT

0201156033818; marwa.elsaid@cu.edu.eg

marwa elsayed

CONTACT

marwa.elsaid@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: March 5, 2024
• Primary Completion: March 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years
• Access Criteria: acceptance the publishing journal

Locations

EG (1)