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

NCT07447037 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006183
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• cardiac troponins

  3 weeks

Study Arms (2)

Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy

EXPERIMENTAL

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; Other: Inspiratory muscle training; Other: Cognitive training; Other: Conventional therapy

Conventional therapy

ACTIVE COMPARATOR

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

Interventions

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.

Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy

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.

Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy

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.

Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy

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.

Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy; Conventional therapy

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cardiology department at El-Kasr El Einy University hospital

Giza, Egypt

Location

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Azza Abdel Aziz, PhD

  Ass. Professor, Cairo University

  STUDY CHAIR

• Alaa Mohamed Naguib, PhD

  Lecturer, Cairo University

  STUDY DIRECTOR

• Ahmed Mohamed Abdelmegeed ElFeky

  Lecturer, Misr University for science and technology

  STUDY DIRECTOR

Central Study Contacts

Hajar Suleiman Zakaria, B.Sc

CONTACT

+20 10 69177694; Hajar.afifi@must.edu.eg

Alaa Mohamed Naguib, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: March 7, 2026
• Primary Completion: April 22, 2026
• Study Completion: April 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

EG (1)