StrokeNCT06450054
Effects of Aerobic Training in Diabetic vs Non-Diabetic Post-Stroke Patients
A study testing Aerobic Exercise in diabetic post-stroke patients and Aerobic Exercise in Non diabetic post-stroke patients in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
The study aims to investigate the effects of aerobic training in post-stroke patients, both diabetic and non-diabetic, in terms of their metabolic response to exercise and psychosocial well-being. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic Exercise in diabetic post-stroke patients and Aerobic Exercise in Non diabetic post-stroke patients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 29 Oct 2024
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female post-stroke patients will be inactive or insufficiently active.
- The Patient's age ranged from 18 to 74. They will have a balanced sitting position or can ambulate.
- The stroke will not last less than six months and not more than two years.
- Exercises will be performed at a vigorous intensity greater than 60% of the individual's maximum cardiorespiratory capacity.
- Patients with adequate cognitive abilities (Mini-Mental Scale >24) to understand and obey instructions
Who cannot join
- Unconscious patients or communication problems that could prevent them from completing the tests used in the study.
- Those with bilateral or previous hemiplegia and sensory aphasia
- Comorbid neurological diseases (multiple sclerosis, Parkinson's disease, spinal cord injury, traumatic brain injury, brain tumour, etc.
- Those with any contraindications for the maximum exercise test
- Cardiovascular or pulmonary conditions (unsettled angina, current myocardial infarction during the last three months, congestive heart failure, severe heart valve dysfunction)
- Musculoskeletal problems such as extreme arthritis and fracture
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
IMC Physical Therapy Hospital (Neuro-Rehab Department) DHA
Lahore
About this study
The study aims to investigate the effects of aerobic training in post-stroke patients, both diabetic and non-diabetic, in terms of their metabolic response to exercise and psychosocial well-being. It is crucial to understand the metabolic changes that occur due to stroke and diabetes, including glucose and lipid profiles.
Read the detailed description
The study will explore how aerobic training can influence insulin sensitivity and lipid metabolism differently in diabetic and non-diabetic patients, which may affect overall recovery outcomes. It is also essential to assess psychosocial well-being, including depression and satisfaction with life. Aerobic exercise has been shown to improve mood and enhance overall quality of life in post-stroke patients. By assessing these variables comprehensively, tailored rehabilitation strategies can be developed to optimise metabolic and psychosocial outcomes in diabetic and non-diabetic post-stroke populations, ultimately improving overall well-being and quality of life.
- Conditions
- Stroke
- Being tested
- Aerobic Exercise in diabetic post-stroke patients, Aerobic Exercise in Non diabetic post-stroke patients
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise in diabetic post-stroke patientsDiagnostic test
The experimental group's members will use the treadmill for a five-minute warm-up and cool-down. Over 12 weeks, they will attend three 40-minute weekly sessions in groups of two to four. They will then perform aerobic exercise for thirty minutes at a heart rate reserve of 60% to 80%. Those with a low exercise tolerance will first be given small workouts lasting at least ten minutes, interspersed with rest periods until they can perform 30 minutes of exercise. They will progress to longer, continuous workouts punctuated by shorter rest periods as their tolerance to exercise grows. The degree of treadmill training intensity will be adjusted step-by-step according to each person's tolerance, heart rate, blood pressure responses, and perceived effort rate. If they exercise beyond their cardiovascular conditioning zone, participants will be instructed to raise their treadmill speed until they achieve it
Aerobic Exercise in Non diabetic post-stroke patientsOther
Group B will be managed aerobic exercise in non-diabetic post-stroke patients. Participants in the control group will walk outside comfortably while maintaining a heart rate reserve of less than 40%. They will be instructed to reduce their pace until their training zone reaches ≤40% if their heart rate reserve exceeds 40%. If the efficacy is demonstrated, participants in the control group will receive the experimental intervention
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise in diabetic post-stroke patients | Active comparator | Not described Receives: Diagnostic Test: Aerobic Exercise in diabetic post-stroke patients |
| Aerobic Exercise in Non diabetic post-stroke patients | Sham comparator | Not described Receives: Other: Aerobic Exercise in Non diabetic post-stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI)
scores range from 0 to 63 or 84, indicating the severity of depressive symptoms. Higher scores signify more severe depression: 0-9 (minimal), 10-18 (mild), 19-29 (moderate), and 30-63 or 30-84 (severe).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450054
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/714
- Status last verified
- Jun 2024
- First submitted
- 25 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training in Diabetic vs Non-Diabetic Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT06450054
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/714
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 10 Jun 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.
The study aims to investigate the effects of aerobic training in post-stroke patients, both diabetic and non-diabetic, in terms of their metabolic response to exercise and psychosocial well-being. It is crucial to understand the metabolic changes that occur due to stroke and diabetes, including glucose and lipid profiles.
Detailed description
The study will explore how aerobic training can influence insulin sensitivity and lipid metabolism differently in diabetic and non-diabetic patients, which may affect overall recovery outcomes. It is also essential to assess psychosocial well-being, including depression and satisfaction with life. Aerobic exercise has been shown to improve mood and enhance overall quality of life in post-stroke patients. By assessing these variables comprehensively, tailored rehabilitation strategies can be developed to optimise metabolic and psychosocial outcomes in diabetic and non-diabetic post-stroke populations, ultimately improving overall well-being and quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise in diabetic post-stroke patients | Active comparator | Diagnostic Test: Aerobic Exercise in diabetic post-stroke patients |
| Aerobic Exercise in Non diabetic post-stroke patients | Sham comparator | Other: Aerobic Exercise in Non diabetic post-stroke patients |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female post-stroke patients will be inactive or insufficiently active.
- The Patient's age ranged from 18 to 74. They will have a balanced sitting position or can ambulate.
- The stroke will not last less than six months and not more than two years.
- Exercises will be performed at a vigorous intensity greater than 60% of the individual's maximum cardiorespiratory capacity.
- Patients with adequate cognitive abilities (Mini-Mental Scale >24) to understand and obey instructions
Key exclusion criteria (6 listed)
- Unconscious patients or communication problems that could prevent them from completing the tests used in the study.
- Those with bilateral or previous hemiplegia and sensory aphasia
- Comorbid neurological diseases (multiple sclerosis, Parkinson's disease, spinal cord injury, traumatic brain injury, brain tumour, etc.
- Those with any contraindications for the maximum exercise test
- Cardiovascular or pulmonary conditions (unsettled angina, current myocardial infarction during the last three months, congestive heart failure, severe heart valve dysfunction)
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 Exercise in diabetic post-stroke patientsThe experimental group's members will use the treadmill for a five-minute warm-up and cool-down. Over 12 weeks, they will attend three 40-minute weekly sessions in groups of two to four. They will then perform aerobic exercise for thirty minutes at a heart rate reserve of 60% to 80%. Those with a low exercise tolerance will first be given small workouts lasting at least ten minutes, interspersed with rest periods until they can perform 30 minutes of exercise. They will progress to longer, continuous workouts punctuated by shorter rest periods as their tolerance to exercise grows. The degree of treadmill training intensity will be adjusted step-by-step according to each person's tolerance, heart rate, blood pressure responses, and perceived effort rate. If they exercise beyond their cardiovascular conditioning zone, participants will be instructed to raise their treadmill speed until they achieve it | Diagnostic test | Aerobic Exercise in diabetic post-stroke patients |
| Aerobic Exercise in Non diabetic post-stroke patientsGroup B will be managed aerobic exercise in non-diabetic post-stroke patients. Participants in the control group will walk outside comfortably while maintaining a heart rate reserve of less than 40%. They will be instructed to reduce their pace until their training zone reaches ≤40% if their heart rate reserve exceeds 40%. If the efficacy is demonstrated, participants in the control group will receive the experimental intervention | Other | Aerobic Exercise in Non diabetic post-stroke patients |
Primary outcome
Beck Depression Inventory (BDI)
Time frame: 12 Months
scores range from 0 to 63 or 84, indicating the severity of depressive symptoms. Higher scores signify more severe depression: 0-9 (minimal), 10-18 (mild), 19-29 (moderate), and 30-63 or 30-84 (severe).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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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 Aerobic Exercise in diabetic post-stroke patients and Aerobic Exercise in Non diabetic post-stroke patients in people with Stroke, run by Superior University 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Beck Depression Inventory (BDI) (time frame: 12 Months). 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 10 Jun 2024.