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Not yet recruiting NCT07447037

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

No phase Interventional Acute Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic training, Inspiratory muscle training, Cognitive training, Conventional therapy.
Who it may be relevant to
Registry conditions: Acute Heart Failure. Basic parameters: 50 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Functional Exercise Capacity [Time frame: 3 weeks]
  • Peak Oxygen Consumption [Time frame: 3 weeks]
  • Inspiratory Muscle Strength [Time frame: 3 weeks]
  • Expiratory Muscle Strength [Time frame: 3 weeks]
  • Cognitive Function [Time frame: 3 weeks]
Secondary outcome measures (1)
  • cardiac troponins [Time frame: 3 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cardiology department at El-Kasr El Einy University hospital — Giza

Identifiers

NCT: NCT07447037 · P.T.REC/012/006183

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗