Exercise and Cognition Among Stroke Survivors

NCT06848998 | Completed

• 1 other identifier: 17/EE/0409
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness

  Cardiorespiratory fitness was measured by means of a cardiopulmonary exercise test (CPET). Participants were allocated to the order of CPET mode: (1) treadmill with body weight support (TBWS) at baseline, followed by cycle ergometer (CE) post-intervention; or (2) CE at baseline, followed by TBWS post-intervention. For the treadmill protocol, participants were suspended by an overhead harness so that they were still weight-bearing but were able to walk using a reciprocal gait pattern with both feet flat on the treadmill. The starting speed was 0.5km/hr and was increased by 0.5 km/hr every one minute, until test termination. For the cycle ergometer protocol, participants pedalled on an upright ergometer at approximately 50 to 60 revolutions per minute, which increased by five watts, every minute, until test termination.

  At baseline, and at the end of the intervention at 8 weeks

Secondary Outcomes (3)

• Cognitive function

  At baseline, and at the end of the intervention at 8 weeks

• Activities of daily living

  At baseline, and at the end of the intervention at 8 weeks

• Stroke specific quality of life

  At baseline, and at the end of the intervention at 8 weeks

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Behavioral: aerobic exercise

Resistance exercise

ACTIVE COMPARATOR

Behavioral: Resistance exercise

Interventions

aerobic exercise 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.

Aerobic exercise

Resistance exercise 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.

Resistance exercise

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leeds Beckett University: lead

Study Sites (1)

University of East Anglia

Norwich, NR4 7TJ, United Kingdom

Location

MeSH Terms

Interventions

Exercise; Resistance Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 27, 2025
• Study Start: April 19, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 30, 2020
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)