Clinical trial NCT04752124: Effects of High-intensity Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke.
Official title: Effect of High Intensity Speed Based Treadmill Training on Balance, Walking Capacity, and Quality in People With Sub-acute Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Cerebrovascular accident
Aerobic exercise
High intensity interval training
Lead sponsor: Government College University Faisalabad
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 high intensity speed based treadmill training on Balance, Walking capacity and quality of life in sub-acute stroke.


Eligibility criteria: Inclusion Criteria:

* age 40-80 years; first episode of stroke; \>4 weeks of stroke onset; hemiparesis resulting from unilateral ischaemic stroke; Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively; mini-mental state examination score ≥23; ability to perform independent walking for at least five minutes with or without an assistive device (FAC=3). All patients will be determined to be in stable cardiovascular condition with a low although slightly greater risk for vigorous exercise than for apparently healthy persons (class B according to the American College of Sports Medicine \[ACSM\]).13

Exclusion Criteria:

* Participants will be excluded from the study if they had any of the following: (1) chronic cardiorespiratory or metabolic diseases; (2) severe osteoporosis; and (3) lesions pertaining to the brainstem or cerebellum; (4) having resting blood pressure above 160/100 mmHg even after taking medications; (5) cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardio-myopathy); (6) transient ischemic attack; (7) by-pass surgery in the recent three months; and (8) other musculoskeletal problems that prevented the participants from doing aerobic activity.

Primary outcomes:
measure: 6 minute walk test
timeFrame: 6 weeks of training
Secondary outcomes:
measure: Berg Balance scale
timeFrame: 5 weeks
measure: Stroke Impact scale
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Bin Inam Rehabilitation Center.
state: Punjab
Study officials:
References:
citation: Lau KW, Mak MK. Speed-dependent treadmill training is effective to improve gait and balance performance in patients with sub-acute stroke. J Rehabil Med. 2011 Jul;43(8):709-13. doi: 10.2340/16501977-0838.