StrokeNCT03507894
Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke.
An observational study of Stroke, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Multimodal Exercise Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2018to 31 Jan 2019
- Phase
- Observational
- 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
Study population: Participants will be stroke survivors who have completed a conventional rehabilitation program. They will be recruited from Hospital-Consorci Sanitari de Terrassa (Barcelona, Spain) over a period of six months.
Who may be able to join
- Diagnosis of ischemic or hemorrhagic stroke
- age ≥18;
- Functional Ambulation Classification (FAC) ≥3
- Barthel Index ≥45
Who cannot join
- Cognitive impairment (Mini Mental State Examination ≤24)
- Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
- Alcohol or other toxic substances abuse
- Decompensated psychiatric disorders that prevented from following a group session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study
The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.
Read the detailed description
This is a 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. The aim of the MERP is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. The mobile app technology complements the MERP in order to achieve long term adherence to healthy physical activity.
- Conditions
- Stroke
- Being tested
- Multimodal Exercise Rehabilitation Program
- Keywords
- rehabilitation, exercise, stroke, adherence
- 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.
Multimodal Exercise Rehabilitation ProgramBehavioural
Rehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology
| Study group | Role | What they receive |
|---|---|---|
| m-health stroke rehabilitation | 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology Receives: Behavioral: Multimodal Exercise Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Adherence will be monitored with an app that will record activity time (walking time and distance)
Measured: 8 weeks
Secondary outcomes (1)
Gait speed
Gait speed will be measured with the Ten Meter Walking Test (10MWT). Participants will be given a 2-meter warm-up distance for walking, preceding the 10-meter distance, and 2 meters beyond the 10 meters. The time that takes to walk 10 meters at a comfortable pace and at their maximum speed will be registered in meters/second
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start3 Apr 2018
- Primary completion28 Dec 2018
- Study completion31 Jan 2019
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Grau-Pellicer, Consorci Sanitari de Terrassa
- Investigators
- Montserrat Grau-Pellicer, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507894
- Sponsor's protocol ID
- ConsorciST
- Status last verified
- Aug 2023
- First submitted
- 16 Apr 2018
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
PubMed 34184251
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study
- ClinicalTrials.gov ID
- NCT03507894
- Acronym / sponsor ID
- ConsorciST
- Conditions
- Stroke
- Keywords
- rehabilitation, exercise, stroke, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 25 Apr 2018 (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.
The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.
Detailed description
This is a 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. The aim of the MERP is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. The mobile app technology complements the MERP in order to achieve long term adherence to healthy physical activity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| m-health stroke rehabilitation | – | Behavioral: Multimodal Exercise Rehabilitation Program8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be stroke survivors who have completed a conventional rehabilitation program. They will be recruited from Hospital-Consorci Sanitari de Terrassa (Barcelona, Spain) over a period of six months.
Key inclusion criteria (4 listed)
- Diagnosis of ischemic or hemorrhagic stroke
- age ≥18;
- Functional Ambulation Classification (FAC) ≥3
- Barthel Index ≥45
Key exclusion criteria (4 listed)
- Cognitive impairment (Mini Mental State Examination ≤24)
- Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
- Alcohol or other toxic substances abuse
- Decompensated psychiatric disorders that prevented from following a group session
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 |
|---|---|---|
| Multimodal Exercise Rehabilitation ProgramRehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology | Behavioural | m-health stroke rehabilitation |
Primary outcome
Adherence
Time frame: 8 weeks
Adherence will be monitored with an app that will record activity time (walking time and distance)
1 secondary outcome
Gait speed
Time frame: 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 31 Aug 2023.
- Derived from this study: PubMed 34184251Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Montserrat Grau-Pellicer, PhD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Consorci Sanitari de Terrassa 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 4 inclusion and 4 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 31 Aug 2023. 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?
Adherence (time frame: 8 weeks). 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 NCT03507894, 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 31 Aug 2023.