Clinical trial NCT06539520: Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life
Official title: Impact of Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia, Spastic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, pre-posttreatment, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: Stroke is a major health problem among Egyptian population; an obvious raise in stroke prevalence in all Egyptian governorates. Most stroke survivors commonly develop disabilities those were correlated with restricted physical activity levels. Stroke survivors' cardio-respiratory fitness has several negative impacts such as elevated risk of being affected by other cardiovascular diseases. So, the current study will be conducted to cover the lack in literature concerning the effect of aerobic training on cardiovascular endurance in stroke survivors aiming to faster recovery and reduce the risk of cardiac dysfunction and recurrent strokes.

Detailed description: Stroke as a cerebrovascular accident has a significant prevalence, as well it was addressed a one of major etiologies for other comorbidities, even mortality. Where, cardiac rehabilitation is a structured exercise program that almost designed to offer an opportunity to break the inactivity cycle, reduce associated cardiovascular risks, also improve perceived confidence and quality of life in stroke survivors . Therefore, aerobic training could be defined as a core component that focuses on cardio-respiratory fitness, walking speed and endurance for stroke survivors. Up on that, this clinical trial will be conducted to investigate the effect of aerobic training on cardiorespiratory fitness and health related quality of life in stroke survivors. It will be conducted on eighty post stroke patient (hemiplegic; 55-65 years old with functional ambulatory category more than 3) from Outpatient clinic of neurological department of El-Kasr El-Aini Hospital. They will be allocated into 2 groups; Group A will involves 40 patients will receive aerobic training program, plus traditional physical therapy program. While, Group B will involves 40 patients will receive traditional physical therapy program only. 6-Menutes walk test, Stroke impact scale are the outcome measures.

Eligibility criteria: Inclusion Criteria:

* Both genders,
* Age range is 55-65 years old,
* Within one year post ischemic stroke,
* Right or left sided stroke,
* hemiplegic and hemiparetic patients,
* Medications include anti-spastics, Beta blockers, ACE inhibitors, and diuretics.
* Functional ambulatory category of three or more,
* Hemodynamic stable,
* Did not participate in any other research study within at least 3 months.

Exclusion Criteria:

* Sever anemia,
* Uncontrolled hypertension, or diabetes mellitus,
* Recent cardiothoracic surgeries,
* Cognitive disorders 'mini mental state exam less than 24'
* Auditory and visual problems,
* Dementia,
* Modified Rankin score 3 or more,
* Seizure,
* Musculoskeletal disorders,
* Stroke or serious head trauma within last 3 months,
* Vertrobrobasilar stroke,

Primary outcomes:
measure: 6-Minutes walk test
timeFrame: Baseline of the study, and after 16 weeks at the end of the study.
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: Baseline of the study, and after 16 weeks at the end of the study.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate
Study officials:
affiliation: Professor of Cardiovascular, Respiratory Disorders
name: Ali F Rahmy, PHD
role: STUDY_DIRECTOR
References: