Acute Heart FailureNCT07447037
Integrating Aerobic, Respiratory, and Cognitive Training in Acute Heart Failure
A study testing Aerobic training, Inspiratory muscle training and Cognitive training in people with Acute Heart Failure, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the impact of integrating aerobic, respiratory and cognitive training in acute heart failure. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Aerobic training, Inspiratory muscle training and Cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alaa Mohamed Naguib, PhD contact
Egypt1 site
Cardiology department at El-Kasr El Einy University hospital
Giza
Hajar Suleiman Zakaria, B.Sc, +20 10 69177694, Hajar.afifi@must.edu.eg
About this study
The purpose of this study is to investigate the impact of integrating aerobic, respiratory and cognitive training in acute heart failure.
Read the 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.
- Conditions
- Acute Heart Failure
- Being tested
- Aerobic training, Inspiratory muscle training, Cognitive training, Conventional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
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 trainingOther
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 trainingOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Secondary outcomes (1)
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 Mar 2026 (estimated)
- Primary completion22 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajar Suleiman Zakaria, Cairo University
- Investigators
- Azza Abdel Aziz, PhD, Study chair, Ass. Professor, Cairo UniversityAlaa Mohamed Naguib, PhD, Study director, Lecturer, Cairo UniversityAhmed Mohamed Abdelmegeed ElFeky, Study director, Lecturer, Misr University for science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447037
- Sponsor's protocol ID
- P.T.REC/012/006183
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Aerobic, Respiratory, and Cognitive Training in Acute Heart Failure
- ClinicalTrials.gov ID
- NCT07447037
- Acronym / sponsor ID
- P.T.REC/012/006183
- Conditions
- Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Mar 2026 (estimated)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy | Experimental | Other: Aerobic training, Other: Inspiratory muscle training, Other: Cognitive training, Other: Conventional therapyTwenty 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. |
| Conventional therapy | Active comparator | Other: Conventional therapyTwenty 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingParticipants 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 | Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy |
| Inspiratory muscle trainingParticipants 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 | Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy |
| Cognitive trainingParticipants 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 | Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy |
| Conventional therapyParticipants 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. | Other | Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy, Conventional therapy |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
cardiac troponins
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa Mohamed Naguib, PhD contact
Azza Abdel Aziz, PhD study chair
Ass. Professor, Cairo University
Alaa Mohamed Naguib, PhD study director
Lecturer, Cairo University
Ahmed Mohamed Abdelmegeed ElFeky study director
Lecturer, Misr University for science and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training, Inspiratory muscle training and Cognitive training in people with Acute Heart Failure, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hajar Suleiman Zakaria, B.Sc (+20 10 69177694, Hajar.afifi@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Exercise Capacity (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.