Effects of Aerobic Training in Diabetic vs Non-Diabetic Post-Stroke Patients

NCT ID: NCT06450054

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-10-29

Brief 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. 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Aerobic Exercise in diabetic post-stroke patients

Group Type: ACTIVE_COMPARATOR

Aerobic Exercise in diabetic post-stroke patients

Intervention Type: DIAGNOSTIC_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 patients

Group Type: SHAM_COMPARATOR

Aerobic Exercise in Non diabetic post-stroke patients

Intervention Type: OTHER

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

Interventions

Aerobic Exercise in diabetic post-stroke patients

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

Intervention Type: DIAGNOSTIC_TEST

Aerobic Exercise in Non diabetic post-stroke patients

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IMC Physical Therapy Hospital (Neuro-Rehab Department) DHA

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/714

Identifier Type: -

Identifier Source: org_study_id