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

NCT06539520 | Recruiting DMC

• 1 other identifier: P.T.REC/012/003588
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia, Spastic

Outcome Measures

Primary Outcomes (1)

• 6-Minutes walk test

  A sub-maximal exercise test will be used to assess aerobic capacity and endurance, and functional capability of stroke survivors. 6-Minutes walk test requires stop watch, measuring/ trundle wheel, 30 meter stretch of unimpeded walk way, 2 cones, pulse oximeter, and Borg breathlessness scale. It has excellent reliability, validity, and responsiveness. Its' gained scoring values will be expressed in meters that if more indicates better recovery.

  Baseline of the study, and after 16 weeks at the end of the study.

Secondary Outcomes (1)

• Stroke Impact Scale

  Baseline of the study, and after 16 weeks at the end of the study.

Study Arms (2)

Aerobic Training Group A

EXPERIMENTAL

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

Other: Aerobic training program; Other: Selected physical therapy program for post stroke patients

Control Group B

OTHER

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

Other: Selected physical therapy program for post stroke patients

Interventions

Aerobic training program 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.

Aerobic Training Group A

Selected physical therapy program for post stroke patients 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.

Aerobic Training Group A; Control Group B

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

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

Giza, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali F Rahmy, PHD

  Professor of Cardiovascular, Respiratory Disorders

  STUDY DIRECTOR

Central Study Contacts

Marihan A Mohamed, B.Sc

CONTACT

+2035676103; info@pt.cu.edu.eg

Shimaa M Ali, PHD

CONTACT

+2035676103; info@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Another researcher via an opaque envelopes involved number defining the 80 post stroke participants, then randomly allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer Physical Therapy

Model Details: Prospective, pre-posttreatment, randomized controlled trial.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

EG (1)