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

NCT06450054 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/714
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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).

  12 Months

Study Arms (2)

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

Interventions

Aerobic Exercise in diabetic post-stroke patients 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 diabetic post-stroke patients

Aerobic Exercise in Non diabetic post-stroke patients 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

Aerobic Exercise in Non diabetic post-stroke patients

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

IMC Physical Therapy Hospital (Neuro-Rehab Department) DHA

Lahore, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: June 10, 2024
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: October 29, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)