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

Effect of Aquatic High Intensity Resistive Training on Cardiac Function and Exercise Capacity in Patients With Chronic Heart Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: aquatic high intensity resistive training; Other: usual care

Detailed Description

It is an interventional study in which 60 chronic heart failure patients estimated to enroll according to random allocation and divided into two groups. 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. Resistance of exercises will be progressed with three different levels: barefoot, small fins and large resistance boots and the training leg will perform all the movements without contact with the pool walls or bottom i.e., non-weight bearing. The intervention will be completed in small groups of 6-8 subjects in a pool heated to 30-32 with two instructors: one ensuring intensity and the other full range of movement. Intensity of the training sessions will be set at "as hard and fast as possible" to ensure maximal muscle contraction. Full range of motion will be strictly controlled for to ensure optimal movement of synovial fluid and exposure of the whole cartilage to the low compressive and shear forces created by the muscle contraction and movement. Training intensity will be monitored using heart rate monitors (Polar Electro Ltd, Kempele, Finland), rate of perceived exertion (RPE) using the Borg 6-20 scale and number of repetitions achieved per movement.

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.

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

Contacts and Locations

• Study Contact: Name: marwa elsayed, PhD; Phone Number: 0201156033818; Email: marwa.elsaid@cu.edu.eg
• Study Contact Backup: Name: marwa elsayed; Email: marwa.elsaid@cu.edu.eg

Study Locations

• Egypt
  • Dokki
    • Cairo, Dokki, Egypt, 11432
      • Recruiting
      • Faculty of physical therapy
      • Contact: marwa M elsayed, phd; Phone Number: 02 01156033818; Email: marwadd999@gmail.com
      • Contact: marwa M elsayed, ph.d; Phone Number: 02 01156033818; Email: marwadd999@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; aquatic high intensity resistive training	Other: aquatic high intensity resistive training; 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.
Active Comparator: control group; usual care	Other: usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise capacity	6 minute walk test distance	12 weeks
physical symptoms of heart failure	Minnesota Living with Heart Failure Questionnaire The questionnaire has 21 items. Assessing the impact of frequent physical symptoms of heart failure	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: marwa elsayed, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P.T.REC/012/005044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: sharing study protocol with other researches
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: acceptance the publishing journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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