Stroke, IschemicNCT04835740
Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke
A study testing High intensity Interval Training in people with Stroke, Ischemic and Cerebrovascular Accident, run by Akhtar Saeed Medical and Dental College at 1 site in Pakistan.
Trial summary
Hemiplegia is one of the most common sequelae of stroke. Stroke is the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Cerebrovascular Accident
- What is being tested?
- High intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2020to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age.
- Ischemic Stroke that occurred in the recent 3 months.
- Who can walk independently or by using assistive device.
- Have a minimum Chedoke McMaster Stroke Assessment (CMSA) leg impairment score of 3 but less than 7.
Who cannot join
- Patients were excluded from the study if they have a stroke that occurs more than 3 months.
- Hemorrhagic Stroke.
- If resting blood pressure more than 160/100 even after taking medications
- Have by-pass surgery in recent 3 months.
- Other musculoskeletal problems which restrict the patient's ability to do aerobic activity.
Trial locations and contacts
1 site in 1 country.
About this study
Hemiplegia is one of the most common sequelae of stroke. Stroke is the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen.
The purpose of this study is to Determine the effect of Aerobic exercise training on Balance, Walking capacity and quality of life in sub-acute stroke.
- Conditions
- Stroke, Ischemic, Cerebrovascular Accident
- Being tested
- High intensity Interval Training
- Keywords
- Cerebrovascular accident, Treadmill Training, High-intensity interval training, Walking capacity.
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity Interval TrainingOther
All the participants underwent 5 weeks of High intensity interval training.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Based on the functional capacity of each participant, customized Aerobic exercise plan was designed by the on-site physiotherapist. Receives: Other: High intensity Interval Training |
| Combined Training (conventional rehabilitation plus high-intensity interval training): | Experimental | The patients received 40 minutes of High intensity interval treadmill training in addition to their normal conventional rehabilitation. Receives: Other: High intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute walk Test
To determine the cardiorespiratory fitness of individual after sub-acute stroke.
Measured: 5 weeks
Secondary outcomes (2)
Berg Balance test and rating scale
The scale is used to determine the Balance and stability of patient. Total score of the scale is 56. A score of < 45 indicates individuals may be at greater risk of falling.
Measured: 5 weeks
Stroke Impact scale
The scale is used to measure the impairment and quality of life after stroke. The scale consists of 8 domains. In this study, only 4 domains related to hand function ,strength, mobility and Activity of daily living were used.The maximum score is 140.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start5 Oct 2020
- Primary completion15 Nov 2020
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akhtar Saeed Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Memoona Azhar, Akhtar Saeed Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835740
- Sponsor's protocol ID
- IRB/ASCRH/0006/2020
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT04835740
- Acronym / sponsor ID
- IRB/ASCRH/0006/2020
- Conditions
- Stroke, Ischemic, Cerebrovascular Accident
- Keywords
- Cerebrovascular accident, Treadmill Training, High-intensity interval training, Walking capacity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Akhtar Saeed Medical and Dental CollegeUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 8 Apr 2021 (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.
Hemiplegia is one of the most common sequelae of stroke. Stroke is the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen.
The purpose of this study is to Determine the effect of Aerobic exercise training on Balance, Walking capacity and quality of life in sub-acute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Other: High intensity Interval TrainingBased on the functional capacity of each participant, customized Aerobic exercise plan was designed by the on-site physiotherapist. |
| Combined Training (conventional rehabilitation plus high-intensity interval training): | Experimental | Other: High intensity Interval TrainingThe patients received 40 minutes of High intensity interval treadmill training in addition to their normal conventional rehabilitation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 75 years of age.
- Ischemic Stroke that occurred in the recent 3 months.
- Who can walk independently or by using assistive device.
- Have a minimum Chedoke McMaster Stroke Assessment (CMSA) leg impairment score of 3 but less than 7.
Key exclusion criteria (5 listed)
- Patients were excluded from the study if they have a stroke that occurs more than 3 months.
- Hemorrhagic Stroke.
- If resting blood pressure more than 160/100 even after taking medications
- Have by-pass surgery in recent 3 months.
- Other musculoskeletal problems which restrict the patient's ability to do aerobic 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 |
|---|---|---|
| High intensity Interval TrainingAll the participants underwent 5 weeks of High intensity interval training. | Other | Combined Training (conventional rehabilitation plus high-intensity interval training):, Conventional Rehabilitation |
Primary outcome
6 Minute walk Test
Time frame: 5 weeks
To determine the cardiorespiratory fitness of individual after sub-acute stroke.
2 secondary outcomes
Berg Balance test and rating scale
Time frame: 5 weeks
Stroke Impact scale
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity Interval Training in people with Stroke, Ischemic and Cerebrovascular Accident, run by Akhtar Saeed Medical and Dental College at 1 site in Pakistan.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Apr 2021. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute walk Test (time frame: 5 weeks). 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 8 Apr 2021.