Cerebrovascular StrokeNCT04377022
Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.
A study testing Combined Therapy (Aerobic Exercise in addition to conventional therapy) in people with Cerebrovascular Stroke and Cerebrovascular Accident, Acute, run by Government College University Faisalabad at 1 site in Pakistan.
Trial summary
Stroke is one of the major cause of morbidity and mortality and 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Stroke, Cerebrovascular Accident, Acute, Cerebral Stroke
- What is being tested?
- Combined Therapy (Aerobic Exercise in addition to conventional therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2019to 10 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age.
- 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.
- 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.
Pakistan1 site
Bin-Inam Rehabilitation Clinic Faisalabad
Faisalabad, Punjab Province, 38000
About this study
Stroke is one of the major cause of morbidity and mortality and 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.
- Being tested
- Combined Therapy (Aerobic Exercise in addition to conventional therapy)
- Keywords
- Aerobic exercise, Stroke, Walking Capacity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Therapy (Aerobic Exercise in addition to conventional therapy)Other
There are two intervention arm in the study
- Combined therapy
- Conventional Therapy
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | No intervention | In this group, Patients receive Conventional Therapy for 40 minutes daily and 5 days in a week. The training period was 5 week after the recruitment of patients. |
| Combined Therapy | Experimental | In this group, Patients receive Aerobic exercise training in addition to conventional Physical Therapy. Patients undergoes Aerobic exercise training for 25 minutes and 3 days in a week. A total of 15 session of aerobic exercise training session was given to patient. Receives: Other: Combined Therapy (Aerobic Exercise in addition to conventional therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute walk Test:
To measure the physical performance of individual after stroke.
Measured: 5 week
Secondary outcomes (2)
Berg Balance test and rating scale
It is use o measure 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 week
Stroke Impact scale
To measure the impairment and quality of life after stroke. The maximum score is 140.
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Dec 2019
- Primary completion8 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular StrokeStudies 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
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishtiaq Ahmed, Government College University Faisalabad
- Investigators
- Awais bin Inam, MSOMPT, Principal investigator, Government College University, Faislabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377022
- Sponsor's protocol ID
- 342
- Status last verified
- Jul 2020
- First submitted
- 4 May 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.
- ClinicalTrials.gov ID
- NCT04377022
- Acronym / sponsor ID
- 342
- Keywords
- Aerobic exercise, Stroke, Walking Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 6 May 2020 (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 one of the major cause of morbidity and mortality and 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 Therapy | No intervention | –In this group, Patients receive Conventional Therapy for 40 minutes daily and 5 days in a week. The training period was 5 week after the recruitment of patients. |
| Combined Therapy | Experimental | Other: Combined Therapy (Aerobic Exercise in addition to conventional therapy)In this group, Patients receive Aerobic exercise training in addition to conventional Physical Therapy. Patients undergoes Aerobic exercise training for 25 minutes and 3 days in a week. A total of 15 session of aerobic exercise training session was given to patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 75 years of age.
- 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 (4 listed)
- Patients were excluded from the study if they have a stroke that occurs more than 3 months.
- 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 |
|---|---|---|
| Combined Therapy (Aerobic Exercise in addition to conventional therapy)There are two intervention arm in the study 1. Combined therapy 2. Conventional Therapy | Other | Combined Therapy |
Primary outcome
6 Minute walk Test:
Time frame: 5 week
To measure the physical performance of individual after stroke.
2 secondary outcomes
Berg Balance test and rating scale
Time frame: 5 week
Stroke Impact scale
Time frame: 5 week
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 20 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Cerebrovascular Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Awais bin Inam, MSOMPT principal investigator
Government College University, Faislabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Therapy (Aerobic Exercise in addition to conventional therapy) in people with Cerebrovascular Stroke and Cerebrovascular Accident, Acute, run by Government College University Faisalabad 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 4 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 20 Jul 2020. 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 week). 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 20 Jul 2020.