Integrating Aerobic, Respiratory, and Cognitive Training in Acute Heart Failure

The purpose of this study is to investigate the impact of integrating aerobic, respiratory and cognitive training in acute heart failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Heart Failure
• Intervention / Treatment: Other: Aerobic training; Other: Inspiratory muscle training; Other: Cognitive training; Other: Conventional therapy

Detailed Description

Patients with acute heart failure often experience severe dyspnea, muscle weakness, and cognitive decline during hospitalization, which together impair recovery and increase the risk of rehospitalization. Respiratory muscle dysfunction contributes to exercise intolerance and worsened prognosis, highlighting the importance of targeted inspiratory training. Likewise, immobilization leads to peripheral muscle deconditioning, while cognitive impairment is associated with poor adherence to treatment and lower quality of life.

Pharmacological therapies remain the cornerstone of acute heart failure management; however, they do not directly address these functional and cognitive complications. Consequently, non-pharmacological strategies have gained increasing attention as adjunctive treatments, offering potential benefits without the risks of drug-related side effects.

It is hypothesized that patients with acute heart failure require a multidimensional rehabilitation program that simultaneously supports respiratory, muscular, and cognitive functions. The BLM approach-combining arm ergometer exercise, inspiratory muscle training, and computerized cognitive training-may represent a novel, safe, and effective strategy to accelerate recovery, improve functional outcomes, reduce hospital stay, and potentially lower readmission rates.

Few clinical trials have evaluated such an integrative program in the acute hospital setting. If proven effective, this approach could be incorporated into routine cardiac rehabilitation protocols, providing holistic care that addresses both physical and cognitive dimensions of heart failure.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hajar Suleiman Zakaria, B.Sc; Phone Number: +20 10 69177694; Email: Hajar.afifi@must.edu.eg
• Study Contact Backup: Name: Alaa Mohamed Naguib, PhD

Study Locations

• Egypt
  • Giza, Egypt
    • Cardiology department at El-Kasr El Einy University hospital
    • Contact: Hajar Suleiman Zakaria, B.Sc; Phone Number: +20 10 69177694; Email: Hajar.afifi@must.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 50-65 years.
• All patients are male.
• Diagnosed with acute heart failure according to ESC guidelines.
• Hemodynamically stable for at least 24 hours.
• Able to follow simple verbal commands and participate in training.

Exclusion Criteria:

• Unstable angina or recent myocardial infarction (< 4 weeks).
• Severe uncontrolled arrhythmias or advanced atrioventricular block.
• Severe pulmonary disease (e.g., advanced COPD, restrictive lung disease).
• Neurological disorders causing cognitive or motor disability.
• Orthopedic or musculoskeletal conditions preventing upper-limb activity.
• Severe visual or auditory impairment limiting participation in cognitive training.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy; Twenty patients will receive a comprehensive intervention program consisting of aerobic training, inspiratory muscle training, and cognitive training in addition to conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.	Other: Aerobic training; Participants in the experimental group will receive arm ergometer training performed at the bedside for 10-15 minutes, twice daily, at low-to-moderate intensity corresponding to 40-50% of the age-predicted maximum heart rate, under appropriate monitoring. The intervention will be continued throughout the hospitalization period for a minimum duration of three weeks.; Other: Inspiratory muscle training; Participants in the experimental group will receive inspiratory muscle training using a threshold device set at 30% of maximal inspiratory pressure, performed twice daily for 15 minutes per session. The training load will be progressively increased according to patient tolerance, and the intervention will be continued throughout the hospitalization period for a minimum duration of three weeks.; Other: Cognitive training; Participants in the experimental group will receive computerized cognitive training consisting of 20-minute daily sessions targeting attention, memory, and problem-solving abilities. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.; Other: Conventional therapy; Participants in both groups will receive conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
Active Comparator: Conventional therapy; Twenty patients will receive conventional therapy only. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.	Other: Conventional therapy; Participants in both groups will receive conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Exercise Capacity	Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT), a standardized submaximal exercise test that measures the total distance walked on a flat surface within six minutes. The 6MWT reflects the integrated performance of the cardiovascular, respiratory, and musculoskeletal systems and is a clinically meaningful indicator of functional status in patients with acute heart failure.	3 weeks
Peak Oxygen Consumption	Peak oxygen consumption (VO₂ peak) will be estimated using the validated prediction equation developed by Vanhelst et al., which incorporates six-minute walk distance and body mass index. This method provides an indirect assessment of aerobic capacity and cardiorespiratory fitness in patients who are unable to perform maximal exercise testing during hospitalization.	3 weeks
Inspiratory Muscle Strength	Inspiratory muscle strength will be evaluated by measuring maximal inspiratory pressure (MIP or PImax) using a calibrated manometer. This measurement quantifies the maximum static inspiratory pressure generated against an occluded airway and reflects the functional capacity of the inspiratory muscles.	3 weeks
Expiratory Muscle Strength	Expiratory muscle strength will be assessed by measuring maximal expiratory pressure (MEP or PEmax) using a standardized manometer. MEP represents the maximal static pressure produced during forced expiration against an occluded airway and provides an objective measure of global expiratory muscle function.	3 weeks
Cognitive Function	Cognitive function will be assessed using the validated Arabic version of the Montreal Cognitive Assessment (MoCA). This tool evaluates multiple cognitive domains, including attention, memory, executive function, language, and visuospatial abilities, and is suitable for detecting cognitive impairment in patients with acute heart failure.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac troponins	Cardiac troponin levels will be measured as a biomarker of myocardial injury to identify coexisting or precipitating cardiac events and to monitor patient safety during the intervention period.	3 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza Abdel Aziz, PhD, Ass. Professor, Cairo University; Study Director: Alaa Mohamed Naguib, PhD, Lecturer, Cairo university; Study Director: Ahmed Mohamed Abdelmegeed ElFeky, Lecturer, Misr University for science and technology

Study record dates

Study Major Dates

• Study Start (Estimated): March 7, 2026
• Primary Completion (Estimated): April 22, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Neurological Rehabilitation; Cognitive Training
• Other Study ID Numbers: P.T.REC/012/006183

Drug and device information, study documents

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