Hemiplegia, SpasticNCT06539520
Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life
A study testing Aerobic training program and Selected physical therapy program for post stroke patients in people with Hemiplegia, Spastic, run by Adly A Adam at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Hemiplegia, Spastic
- What is being tested?
- Aerobic training program and Selected physical therapy program for post stroke patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to Oct 2025
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Functional ambulatory category of three or more,
- Hemodynamic stable,
- Did not participate in any other research study within at least 3 months.
Who cannot join
- Sever anemia,
- Uncontrolled hypertension, or diabetes mellitus,
- Recent cardiothoracic surgeries,
- Cognitive disorders 'mini mental state exam less than 24'
- Auditory and visual problems,
- Dementia,
Show all 11Show fewer
- Modified Rankin score 3 or more,
- Seizure,
- Musculoskeletal disorders,
- Stroke or serious head trauma within last 3 months,
- Vertrobrobasilar stroke,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
El-Tahrir st.- in front of Ben El-Sarayat, Ad Doqi Al Giza, Giza Governate
Giza, 002
Marihan A Mohamed, B.Sc, +2035676103 ext. 105, info@pt.cu.edu.eg
Shimaa M Ali, PHD, +2035676103 ext. 103, info@pt.edu.eg
About this study
Official title: Impact of Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life in Stroke Survivors
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.
Read the 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
- Being tested
- Aerobic training program, Selected physical therapy program for post stroke patients
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic training programOther
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 patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training Group A | Experimental | Forty post-stroke patients will receive aerobic training program, plus selected physical therapy program. Receives: 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. Receives: Other: Selected physical therapy program for post stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline of the study, and after 16 weeks at the end of the study.
Secondary outcomes (1)
Stroke Impact Scale
A stroke-specific, self-reported, health status measure. It is designed to assess multi-dimensional stroke outcomes involving strength (4 items), hand function (5 items), activities of daily living/ instrumental activities of daily living (10 items), mobility (9 items), communication (7 items), emotion (9 items), memory (7 items), and participation (8 items). The over score ranged from Zero indicating no recovery up to 100 indicating full recovery
Measured: Baseline of the study, and after 16 weeks at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 May 2024
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia, SpasticStudies of the same condition, open and under way.
- 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
- Model description
- Prospective, pre-posttreatment, randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Ali F Rahmy, PHD, Study director, Professor of Cardiovascular, Respiratory Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539520
- Sponsor's protocol ID
- P.T.REC/012/003588
- Status last verified
- Mar 2025
- First submitted
- 29 Jul 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06539520
- Acronym / sponsor ID
- P.T.REC/012/003588
- Conditions
- Hemiplegia, Spastic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, pre-posttreatment, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training Group A | Experimental | Other: Aerobic training program, Other: Selected physical therapy program for post stroke patientsForty post-stroke patients will receive aerobic training program, plus selected physical therapy program. |
| Control Group B | Other | Other: Selected physical therapy program for post stroke patientsForty post-stroke patients will receive selected physical therapy program. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Both genders,
- Age range is 55-65 years old,
- Within one year post ischemic stroke,
- Right or left sided stroke,
- hemiplegic and hemiparetic patients,
Key exclusion criteria (11 listed)
- Sever anemia,
- Uncontrolled hypertension, or diabetes mellitus,
- Recent cardiothoracic surgeries,
- Cognitive disorders 'mini mental state exam less than 24'
- Auditory and visual problems,
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 training programAerobic 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. | Other | Aerobic Training Group A |
| Selected physical therapy program for post stroke patientsSelected 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. | Other | Aerobic Training Group A, Control Group B |
Primary outcome
6-Minutes walk test
Time frame: Baseline of the study, and after 16 weeks at the end of the study.
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.
1 secondary outcome
Stroke Impact Scale
Time frame: Baseline of the study, and after 16 weeks at the end of the study.
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 21 Mar 2025.
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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.
Ali F Rahmy, PHD study director
Professor of Cardiovascular, Respiratory Disorders
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 program and Selected physical therapy program for post stroke patients in people with Hemiplegia, Spastic, run by Adly A Adam 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. 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 Marihan A Mohamed, B.Sc (+2035676103 ext. 105, info@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minutes walk test (time frame: Baseline of the study, and after 16 weeks at the end of the study.). 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 21 Mar 2025.