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NCT Number: NCT07447037

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.

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Key information

Conditions

Acute Heart Failure

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Aerobic training

Other

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.

Inspiratory Muscle Training

Other

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.

Cognitive Training

Other

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.

Conventional Therapy

Other

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.

Primary outcomes

  1. Functional Exercise Capacity

    Time frame: 3 weeks

    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.

  2. Peak Oxygen Consumption

    Time frame: 3 weeks

    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. Inspiratory Muscle Strength

    Time frame: 3 weeks

    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.

  4. Expiratory Muscle Strength

    Time frame: 3 weeks

    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.

  5. Cognitive Function

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. cardiac troponins

    Time frame: 3 weeks

    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.

Study contacts

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

Alaa Mohamed Naguib, PhD

CONTACT

Hajar Suleiman Zakaria, B.Sc

CONTACT

[email protected]

+20 10 69177694

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

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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