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

Not Applicable

Active, not recruiting

• Conditions: Stroke
• Interventions: Diagnostic Test: Aerobic Exercise in diabetic post-stroke patients; Other: Aerobic Exercise in Non diabetic post-stroke patients

• Registration Number: NCT06450054
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-04-01
• Study First Submitted: 2024-05-25
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-10
• Last Update Posted: 2024-06-10
• Study Completion: 2024-10-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise in diabetic post-stroke patients	Aerobic Exercise in diabetic post-stroke patients	-
Aerobic Exercise in Non diabetic post-stroke patients	Aerobic Exercise in Non diabetic post-stroke patients	-

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	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).

Trial Locations

Locations (1)

IMC Physical Therapy Hospital (Neuro-Rehab Department) DHA; 🇵🇰 Lahore, Pakistan