StrokeNCT02543450
Physiotherapy in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
A study testing Cardiovascular and task-oriented training and Upper limb strength training program in people with Stroke, run by University of Valencia at 1 site in Spain.
Trial summary
In hemiplegic stroke patients, gait performance is affected by impaired walking endurance. Evidence has shown that higher exercise intensity improves cardiovascular fitness, while greater dose in task repetition benefits locomotor function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cardiovascular and task-oriented training and Upper limb strength training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to 30 Dec 2015
- 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
- More than 6 months after first stroke
Who cannot join
- Functional disability not related to the aftermath of stroke
- Participate in other rehabilitation programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Different Physiotherapy Programs in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
In hemiplegic stroke patients, gait performance is affected by impaired walking endurance. Evidence has shown that higher exercise intensity improves cardiovascular fitness, while greater dose in task repetition benefits locomotor function. Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.
Read the detailed description
Owing to the high prevalence of disability in stroke older adults, walking capacity and participation can be severely affected. According to the International Classification of Functioning, Disability and Health 2001, participation involves functioning in life. In Rehabilitation Medicine, there has been a growing concern about it as a way to assess success of treatment. However, appraisal of participation in stroke research is scarce.
In all stages after a stroke, Physiotherapy interventions in favor of intensive high repetitive task-oriented and task-specific training have obtained benefits on trained actions and activities. But, the effect of this type of treatment on the impact the disease has on patient´s participation is under investigated.
The aim of this study was to determine which kind of physiotherapy task-oriented training program could better improve participation in chronic stroke subjects: an upper limb strength training program (ULST) or a combined cardiovascular/task-oriented interval training (IT) program.
Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.
A randomized single-blind controlled trial was carried out. Fourteen subjects with chronic hemiplegia resulting from stroke (onset >6m) were recruited. All participants were fully informed about the experimental procedures and the aim of the study. Written informed consent was signed by each subject prior to participate. Approval from the ethics committee of the University of Valencia was obtained for the study.
Subjects were randomly allocated to an ULST program with elastic bands (n=7) or to a cardiovascular/task-oriented IT program (n=7), focused on walking capacity. In the ULST group, a nine 5-minute station circuit session was designed. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations. The IT program consisted of a set of 8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises. Duration of both programmes was 3 months (3 sessions/week).
Participation was assessed by the Stroke Impact Scale (SIS-16) and the Frenchay Activities Index (FAI), before and after the intervention.
- Conditions
- Stroke
- Being tested
- Cardiovascular and task-oriented training, Upper limb strength training program
- Keywords
- Chronic stroke, Participation, Walking ability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular and task-oriented trainingOther
Upper limb strength training programOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular/task-oriented training | Experimental | 8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises. Receives: Other: Cardiovascular and task-oriented training |
| Upper limb strength training program | Active comparator | Nine 5-minute station circuit session. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations. Receives: Other: Upper limb strength training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation (Frenchay Activities Index (FAI))
Frenchay Activities Index (FAI)
Measured: At 3 months
Secondary outcomes (2)
Walking ability
6 min-walk
Measured: At 3 months
Upper limb function (Fugl-Meyer Assessment)
Fugl-Meyer Assessment
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Nueva Opción Brain Damage Association
- Responsible party
- Principal investigator, M Luz Sanchez, University of Valencia
- Investigators
- Sánchez-Sánchez ML, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543450
- Sponsor's protocol ID
- Stroke_Project_15
- Status last verified
- Aug 2020
- First submitted
- 3 Sep 2015
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez-Sanchez ML, Ruescas-Nicolau MA, Perez-Miralles JA, Marques-Sule E, Espi-Lopez GV. Pilot randomized controlled trial to assess a physical therapy program on upper extremity function to counteract inactivity in chronic stroke. Top Stroke Rehabil. 2017 Apr;24(3):183-193. doi: 10.1080/10749357.2016.1245395. Epub 2016 Oct 19.
PubMed 27760505
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Different Physiotherapy Programs in Order to Improve Walking Capacity and Participation in Chronic Stroke Subjects
- ClinicalTrials.gov ID
- NCT02543450
- Acronym / sponsor ID
- Stroke_Project_15
- Conditions
- Stroke
- Keywords
- Chronic stroke, Participation, Walking ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Nueva Opción Brain Damage Association
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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.
In hemiplegic stroke patients, gait performance is affected by impaired walking endurance. Evidence has shown that higher exercise intensity improves cardiovascular fitness, while greater dose in task repetition benefits locomotor function. Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.
Detailed description
Owing to the high prevalence of disability in stroke older adults, walking capacity and participation can be severely affected. According to the International Classification of Functioning, Disability and Health 2001, participation involves functioning in life. In Rehabilitation Medicine, there has been a growing concern about it as a way to assess success of treatment. However, appraisal of participation in stroke research is scarce.
In all stages after a stroke, Physiotherapy interventions in favor of intensive high repetitive task-oriented and task-specific training have obtained benefits on trained actions and activities. But, the effect of this type of treatment on the impact the disease has on patient´s participation is under investigated.
The aim of this study was to determine which kind of physiotherapy task-oriented training program could better improve participation in chronic stroke subjects: an upper limb strength training program (ULST) or a combined cardiovascular/task-oriented interval training (IT) program.
Therefore, the goal of this study is to examine the effect of a combined cardiovascular/task-oriented interval training programme on the walking capacity of chronic stroke individuals and the improvement in their participation.
A randomized single-blind controlled trial was carried out. Fourteen subjects with chronic hemiplegia resulting from stroke (onset >6m) were recruited. All participants were fully informed about the experimental procedures and the aim of the study. Written informed consent was signed by each subject prior to participate. Approval from the ethics committee of the University of Valencia was obtained for the study.
Subjects were randomly allocated to an ULST program with elastic bands (n=7) or to a cardiovascular/task-oriented IT program (n=7), focused on walking capacity. In the ULST group, a nine 5-minute station circuit session was designed. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations. The IT program consisted of a set of 8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises. Duration of both programmes was 3 months (3 sessions/week).
Participation was assessed by the Stroke Impact Scale (SIS-16) and the Frenchay Activities Index (FAI), before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular/task-oriented training | Experimental | Other: Cardiovascular and task-oriented training8 cardiovascular exercises at moderate intensity, interrupted by 1-minute active breaks of task-oriented exercises. |
| Upper limb strength training program | Active comparator | Other: Upper limb strength training programNine 5-minute station circuit session. Patients work 2+2 minutes in each exercise, with a 30-second rest between the 2-minute periods and between stations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- More than 6 months after first stroke
Key exclusion criteria (2 listed)
- Functional disability not related to the aftermath of stroke
- Participate in other rehabilitation programs
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 |
|---|---|---|
| Cardiovascular and task-oriented training | Other | Cardiovascular/task-oriented training |
| Upper limb strength training program | Other | Upper limb strength training program |
Primary outcome
Participation (Frenchay Activities Index (FAI))
Time frame: At 3 months
Frenchay Activities Index (FAI)
2 secondary outcomes
Walking ability
Time frame: At 3 months
Upper limb function (Fugl-Meyer Assessment)
Time frame: At 3 months
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 28 Aug 2020.
- Derived from this study: PubMed 27760505Sanchez-Sanchez ML, Ruescas-Nicolau MA, Perez-Miralles JA, Marques-Sule E, Espi-Lopez GV. Pilot randomized controlled trial to assess a physical therapy program on upper extremity function to counteract inactivity in chronic stroke. Top Stroke Rehabil. 2017 Apr;24(3):183-193. doi: 10.1080/10749357.2016.1245395. Epub 2016 Oct 19.
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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.
Sánchez-Sánchez ML principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular and task-oriented training and Upper limb strength training program in people with Stroke, run by University of Valencia at 1 site in Spain.
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 1 inclusion and 2 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 28 Aug 2020. 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 Spain. 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?
Participation (Frenchay Activities Index (FAI)) (time frame: At 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 NCT02543450, which also lists 1 linked publication.
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 28 Aug 2020.