Clinical trial NCT06848998: Exercise and Cognition Among Stroke Survivors
Official title: Exercise and Cognition Among Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Exercise
Resistance Exercise
Lead sponsor: Leeds Beckett University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aimed to: (1) identify a suitable cardiopulmonary exercise testing protocol for people with moderate to severe movement impairments after stroke by investigating the safety and feasibility of delivering two methods of CPET modes: treadmill with body-weight support (TBWS) and cycle ergometry (CE); and (2) explore the safety and feasibility of a delivering a 6-week exercise-based intervention or people with moderate to severe movement impairments after stroke, with a view to improve cognitive health.


Eligibility criteria: Inclusion Criteria:

* Have provided informed consent,
* Are aged \>18 years,
* Are more than 6 months post-stroke,
* Score 2-3 on the Functional Ambulation Category
* Can follow 1-stage commands i.e. sufficient communication/orientation for interventions in the trial.

Exclusion Criteria:

* Attending any other community exercise class/gym/walking group/rehabilitation class,
* A previous diagnosis of dementia or any other significant cognitive decline,
* Any musculoskeletal or neurophysiological disorder preventing participation in exercise,
* Have uncontrolled hypertension, atrial fibrillation, heart failure or diabetes.
* Weigh over 250lbs/113kg (due to weight restrictions on body-weight support harness on treadmill),
* Meeting any absolute or relative contraindication to exercise from American College of Sports Medicine (ACSM)

Contraindications to Exercise 2014, see below:

Absolute contraindications to exercise:

* A recent significant change in the resting ECG suggesting significant ischaemia, recent myocardial infarction (within 2 days) or other acute cardiac event
* Unstable angina
* Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
* Symptomatic severe aortic stenosis
* Uncontrolled symptomatic heart failure
* Actuate pulmonary embolus or pulmonary infarction
* Acute myocarditis or pericarditis
* Suspected or know dissecting aneurysm
* Acute systematic infection, accompanied by fever, body aches or swollen lymph glands

Relative contraindications to exercise:

* Left main coronary stenosis
* Moderate stenotic valvular heart disease
* Electrolyte abnormalities e.g. hypokalaemia, hypo-magnesia
* Severe arterial hypertensions i.e. systolic BP of \>200mmHg and/or diastolic BP of \>110mmHg at rest
* Tachydysrthythmia or bradydsrhythmia
* Hypertrophic cardiomyopathy and other forms of outflow tract obstruction
* Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
* High-degree atrioventricular block
* Ventricular aneurysm
* Uncontrolled metabolic disease e.g. diabetes, thyrotoxosis or myxedemia Chronic infectious diseases e.g. mononucleosis, hepatitis, AIDs
* Mental or physical impairment leading to inability to exercise adequately

Primary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: At baseline, and at the end of the intervention at 8 weeks
Secondary outcomes:
measure: Cognitive function
timeFrame: At baseline, and at the end of the intervention at 8 weeks
measure: Activities of daily living
timeFrame: At baseline, and at the end of the intervention at 8 weeks
measure: Stroke specific quality of life
timeFrame: At baseline, and at the end of the intervention at 8 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
Study officials:
References: