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NCT Number: NCT06297707

Effect of Aquatic High Intensity Resistive Training on 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.

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Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Cardiac function

    Time frame: 12 weeks

    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

Secondary outcomes

  1. exercise capacity

    Time frame: 12 weeks

    6 minute walk test distance

  2. physical symptoms of heart failure

    Time frame: 12 weeks

    Minnesota Living with Heart Failure Questionnaire The questionnaire has 21 items. Assessing the impact of frequent physical symptoms of heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

marwa elsayed

CONTACT

[email protected]

marwa elsayed, PhD

CONTACT

[email protected]

0201156033818

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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