Exercise and Cognition Among Stroke Survivors

NCT ID: NCT06848998

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2020-07-30

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.

Conditions

Aerobic Exercise; Resistance Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic exercise

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: BEHAVIORAL

40 minutes of aerobic exercise, twice per week for six weeks.

Sessions comprised of the following: 10-minute warm-up, 40-minute conditioning period as a circuit, and 10-minute cool-down.

Aerobic exercises (for example, recumbent cycling, stepping, arm crank) commenced at an intensity of 40-50% heart rate reserve (HRR) and increased incrementally by 10% as tolerated, up to a maximum of 70-80%. All sessions were individually tailored as far as possible to participants' needs, abilities, and preferences.

Resistance exercise

Group Type: ACTIVE_COMPARATOR

Resistance exercise

Intervention Type: BEHAVIORAL

4 x resistance exercises (3 sets of 6 repetitions), twice per week for six weeks.

Strengthening exercises (for example, resistance band work) were prescribed at an intensity that corresponded to 11-12 and incrementally increased to a maximum of 14-15, as tolerated, on the Borg Ratings of Perceived Exertion (RPE) 6-20 Scale. All sessions were individually tailored as far as possible to participants' needs, abilities, and preferences.

Interventions

Resistance exercise

4 x resistance exercises (3 sets of 6 repetitions), twice per week for six weeks.

Strengthening exercises (for example, resistance band work) were prescribed at an intensity that corresponded to 11-12 and incrementally increased to a maximum of 14-15, as tolerated, on the Borg Ratings of Perceived Exertion (RPE) 6-20 Scale. All sessions were individually tailored as far as possible to participants' needs, abilities, and preferences.

Intervention Type: BEHAVIORAL

aerobic exercise

40 minutes of aerobic exercise, twice per week for six weeks.

Sessions comprised of the following: 10-minute warm-up, 40-minute conditioning period as a circuit, and 10-minute cool-down.

Aerobic exercises (for example, recumbent cycling, stepping, arm crank) commenced at an intensity of 40-50% heart rate reserve (HRR) and increased incrementally by 10% as tolerated, up to a maximum of 70-80%. All sessions were individually tailored as far as possible to participants' needs, abilities, and preferences.

Intervention Type: BEHAVIORAL

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

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

Sponsors

Leeds Beckett University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of East Anglia

Norwich, , United Kingdom

Countries

United Kingdom

Other Identifiers

17/EE/0409

Identifier Type: -

Identifier Source: org_study_id