Cerebrovascular AccidentTOTSNCT01322607
Task-oriented Training for Stroke: Impact on Function Mobility
A study testing High-intensity Treadmill Exercise and Low-intensity Lifestyle Intervention in people with Cerebrovascular Accident and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cerebrovascular Accident, Stroke
- What is being tested?
- High-intensity Treadmill Exercise and Low-intensity Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years.
- Completion of all regular post-stroke physical therapy
- Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent.
- Able to rise from a chair unaided.
- Able to walk 10 meters without human assistance.
Who cannot join
- Regular structured aerobic exercise (> 2x week).
- Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report.
- Clinical history of
- unstable angina,
- recent (< 3 months) myocardial infarction or congestive heart failure (NYHA category II),
- hemodynamically significant valvular dysfunction,
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- Peripheral Arterial Obstructive Disease with claudication,
- major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise,
- pulmonary or renal failure,
- poorly controlled hypertension (>190/110), measured on at least two separate occasions
- recent hospitalization for severe disease or surgery
- severe or global receptive aphasia which confounds reliable testing and training.
- Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of >16 and confirmed by clinical interview.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.
- Conditions
- Cerebrovascular Accident, Stroke
- Being tested
- High-intensity Treadmill Exercise, Low-intensity Lifestyle Intervention
- Keywords
- Exercise, Rehabilitation, Stroke
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity Treadmill ExerciseBehavioural
High-intensity treadmill walking program
Low-intensity Lifestyle InterventionBehavioural
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: High-Intensity Program | Other | High-intensity treadmill-based exercise Receives: Behavioral: High-intensity Treadmill Exercise |
| Arm 2: Low-Intensity Program | Other | Low-intensity lifestyle intervention (group exercise) Receives: Behavioral: Low-intensity Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Economy of Gait
Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.
Measured: 3 months
Secondary outcomes (3)
Muscular Strength
Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.
Measured: 3 months
Muscular Endurance
Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.
Measured: 3 months
Balance
Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alyssa D Stookey, PhD MS, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322607
- Sponsor's protocol ID
- O7194-W
- Acronym
- TOTS
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2011
- Last updated
- 6 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Liu X, Zhang Y, Li F, Liu L, Du J, Song WQ. Test-retest reliability and practice effects of shape trail test in stroke patients. Top Stroke Rehabil. 2025 Oct;32(7):779-788. doi: 10.1080/10749357.2025.2457282. Epub 2025 Mar 13.
PubMed 40079581Stookey AD, Macko RF, Ivey FM, Katzel LI. Evaluating Test-Retest Reliability of Fatigability in Chronic Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105895. doi: 10.1016/j.jstrokecerebrovasdis.2021.105895. Epub 2021 Jul 7.
PubMed 34242857
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Training for Stroke: Impact on Function Mobility
- ClinicalTrials.gov ID
- NCT01322607
- Acronym / sponsor ID
- TOTS / O7194-W
- Conditions
- Cerebrovascular Accident, Stroke
- Keywords
- Exercise, Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Posted 6 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: High-Intensity Program | Other | Behavioral: High-intensity Treadmill ExerciseHigh-intensity treadmill-based exercise |
| Arm 2: Low-Intensity Program | Other | Behavioral: Low-intensity Lifestyle InterventionLow-intensity lifestyle intervention (group exercise) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke > 6 months prior with residual hemiparetic gait in women or men aged 40-85 years.
- Completion of all regular post-stroke physical therapy
- Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent.
- Able to rise from a chair unaided.
- Able to walk 10 meters without human assistance.
Key exclusion criteria (14 listed)
- Regular structured aerobic exercise (> 2x week).
- Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report.
- Clinical history of
- Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of >16 and confirmed by clinical interview.
- Pregnancy.
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 |
|---|---|---|
| High-intensity Treadmill ExerciseHigh-intensity treadmill walking program | Behavioural | Arm 1: High-Intensity Program |
| Low-intensity Lifestyle InterventionA low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength. | Behavioural | Arm 2: Low-Intensity Program |
Primary outcome
Economy of Gait
Time frame: 3 months
Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.
3 secondary outcomes
Muscular Strength
Time frame: 3 months
Muscular Endurance
Time frame: 3 months
Balance
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40079581Liu X, Zhang Y, Li F, Liu L, Du J, Song WQ. Test-retest reliability and practice effects of shape trail test in stroke patients. Top Stroke Rehabil. 2025 Oct;32(7):779-788. doi: 10.1080/10749357.2025.2457282. Epub 2025 Mar 13.
- Derived from this study: PubMed 34242857Stookey AD, Macko RF, Ivey FM, Katzel LI. Evaluating Test-Retest Reliability of Fatigability in Chronic Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105895. doi: 10.1016/j.jstrokecerebrovasdis.2021.105895. Epub 2021 Jul 7.
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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.
Alyssa D Stookey, PhD MS principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity Treadmill Exercise and Low-intensity Lifestyle Intervention in people with Cerebrovascular Accident and Stroke, run by VA Office of Research and Development at 1 site in United States.
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 14 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 6 Apr 2016. 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 States. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Economy of Gait (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322607, which also lists 2 linked publications.
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 6 Apr 2016.