An interventional study of aquatic high intensity resistive training and usual care in Heart Failure, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Age ranges from 45 to 60 years old. Have chronic heart failure (NYHA class I to III).
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)
aquatic high intensity resistive training
Other: aquatic high intensity resistive training
usual care
Other: usual care
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.
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.
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
Time frame: 12 weeks
exercise capacity
6 minute walk test distance
Time frame: 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
Time frame: 12 weeks
Plan to share: Yes — sharing study protocol with other researches
Supporting information: Study protocol
Time frame: 2 years
Access criteria: acceptance the publishing journal
Data sharing details ↗ · www.ekb.com
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2025, 12 months after the start.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 12 months is below that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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