Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life

NCT ID: NCT06539520

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-10-31

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.

Conditions

Hemiplegia, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aerobic Training Group A

Forty post-stroke patients will receive aerobic training program, plus selected physical therapy program.

Group Type: EXPERIMENTAL

Aerobic training program

Intervention Type: OTHER

Aerobic training program; on interval moderate mode, 3 session per week, for 16 weeks, along 30-40 minutes, plus 5-10 minutes of warm up and 5 minutes cooling down, with 50-80% of maximal heart rate for each patient based on age. that progress every month by 10% directed by rating of perceived exertion.

Selected physical therapy program for post stroke patients

Intervention Type: OTHER

Selected neurorehabilitation for 1 hour session; 3 sessions per week, for 16 weeks. It involves weight shift side to side, reaching toward weak side, shoulder flexion overhead, shoulder external rotation, overhead press, shoulder internal rotation with Thera-band, heel slides, bridging, lying terminal knee extension, toe and heel raises, sensory reeducation exercises, and body awareness therapy.

Control Group B

Forty post-stroke patients will receive selected physical therapy program.

Group Type: OTHER

Selected physical therapy program for post stroke patients

Intervention Type: OTHER

Selected neurorehabilitation for 1 hour session; 3 sessions per week, for 16 weeks. It involves weight shift side to side, reaching toward weak side, shoulder flexion overhead, shoulder external rotation, overhead press, shoulder internal rotation with Thera-band, heel slides, bridging, lying terminal knee extension, toe and heel raises, sensory reeducation exercises, and body awareness therapy.

Interventions

Aerobic training program

Aerobic training program; on interval moderate mode, 3 session per week, for 16 weeks, along 30-40 minutes, plus 5-10 minutes of warm up and 5 minutes cooling down, with 50-80% of maximal heart rate for each patient based on age. that progress every month by 10% directed by rating of perceived exertion.

Intervention Type: OTHER

Selected physical therapy program for post stroke patients

Selected neurorehabilitation for 1 hour session; 3 sessions per week, for 16 weeks. It involves weight shift side to side, reaching toward weak side, shoulder flexion overhead, shoulder external rotation, overhead press, shoulder internal rotation with Thera-band, heel slides, bridging, lying terminal knee extension, toe and heel raises, sensory reeducation exercises, and body awareness therapy.

Intervention Type: OTHER

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,

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adly A Adam

OTHER

Sponsor Role: lead

Responsible Party

Adly A Adam

Lecturer Physical Therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ali F Rahmy, PHD

Role: STUDY_DIRECTOR

Professor of Cardiovascular, Respiratory Disorders

Locations

El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marihan A Mohamed, B.Sc

Role: CONTACT

info@pt.cu.edu.eg

+2035676103 ext. 105

Shimaa M Ali, PHD

Role: CONTACT

info@pt.cu.edu.eg

+2035676103 ext. 103

Facility Contacts

Marihan A Mohamed, B.Sc

Role: primary

info@pt.cu.edu.eg

+2035676103 ext. 105

Shimaa M Ali, PHD

Role: backup

info@pt.edu.eg

+2035676103 ext. 103

Other Identifiers

P.T.REC/012/003588

Identifier Type: -

Identifier Source: org_study_id