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

NCT ID: NCT06297707

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-12-30

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

experimental group

aquatic high intensity resistive training

Group Type: EXPERIMENTAL

aquatic high intensity resistive training

Intervention Type: 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.

control group

usual care

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

marwa mahmoud elsayed mahmoud

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

marwa elsayed

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Physical Therapy

Cairo, Dokki, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

marwa elsayed, PhD

Role: CONTACT

marwa.elsaid@cu.edu.eg

0201156033818

marwa elsayed

Role: CONTACT

marwa.elsaid@cu.edu.eg

Facility Contacts

marwa M elsayed, phd

Role: primary

marwadd999@gmail.com

01156033818 ext. 02

marwa M elsayed, ph.d

Role: backup

marwadd999@gmail.com

01156033818 ext. 02

Other Identifiers

P.T.REC/012/005044

Identifier Type: -

Identifier Source: org_study_id