Aerobic ExerciseEXERCISESNCT06848998
Exercise and Cognition Among Stroke Survivors
A study testing aerobic exercise and Resistance exercise in people with Aerobic Exercise and Resistance Exercise, run by Leeds Beckett University at 1 site in United Kingdom.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aerobic Exercise, Resistance Exercise
- What is being tested?
- aerobic exercise and Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- aerobic exercise, Resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Not described Receives: Behavioral: aerobic exercise |
| Resistance exercise | Active comparator | Not described Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, and at the end of the intervention at 8 weeks
Secondary outcomes (3)
Cognitive function
Cognition was measured using the Montreal Cognitive Assessment (MoCA). The minimum score is 0 (indicating severe cognitive impairment) and the maximum score is 30 (indicating normal cognitive function). Scores of lower than 26 may indicate varying levels of cognitive impairment.
Measured: At baseline, and at the end of the intervention at 8 weeks
Activities of daily living
Activities of daily living (ADL) was measured using the Barthel Index. Each activity (e.g., feeding, bathing, grooming) is scored based on the level of assistance required. The total score ranges from 0 to 100, with higher scores indicating greater independence.
Measured: At baseline, and at the end of the intervention at 8 weeks
Stroke specific quality of life
Quality of life (QoL) was measured using the Stroke Specific Quality of Life Questionnaire (SSQoL). Each domain (e.g., mood, personality, social roles) consists of items scored from 1 to 5. The total SS-QOL score ranges from 49 to 245, where higher scores suggest a better stroke-related quality of life.
Measured: At baseline, and at the end of the intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start19 Apr 2018
- Primary completion31 Jul 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848998
- Sponsor's protocol ID
- 17/EE/0409
- Acronym
- EXERCISES
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the lead contact (AW) upon reasonable request. This includes access to the full protocol and anonymised participant-level dataset.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Cognition Among Stroke Survivors
- ClinicalTrials.gov ID
- NCT06848998
- Acronym / sponsor ID
- EXERCISES / 17/EE/0409
- Conditions
- Aerobic Exercise, Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: aerobic exercise |
| Resistance exercise | Active comparator | Behavioral: Resistance exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (29 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise40 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. | Behavioural | Aerobic exercise |
| Resistance exercise4 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. | Behavioural | Resistance exercise |
Primary outcome
Cardiorespiratory Fitness
Time frame: At baseline, and at the end of the intervention at 8 weeks
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.
3 secondary outcomes
Cognitive function
Time frame: At baseline, and at the end of the intervention at 8 weeks
Activities of daily living
Time frame: At baseline, and at the end of the intervention at 8 weeks
Stroke specific quality of life
Time frame: At baseline, and at the end of the intervention at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the lead contact (AW) upon reasonable request. This includes access to the full protocol and anonymised participant-level dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and Resistance exercise in people with Aerobic Exercise and Resistance Exercise, run by Leeds Beckett University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: At baseline, and at the end of the intervention at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.