StrokeTPT-StrokeNCT06780891
Effectiveness of Telephysical Therapy as a Secondary Stroke Prevention Tool in Patients With Minor Stroke.
A study testing Telephysical therapy and Educational session in people with Stroke and Physical Therapy Modality, run by University of Cadiz at 1 site in Spain.
Trial summary
This study investigates the effectiveness of telephysiotherapy as a rehabilitation and secondary prevention tool in patients with minor stroke, TIA, or LACI, comparing an experimental group receiving tele-assisted aerobic and anaerobic exercises to a control group. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke, Physical Therapy Modality, Secondary Prevention
- What is being tested?
- Telephysical therapy and Educational session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2025to 1 May 2025
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Subjects with a diagnosis of minor stroke, TIA, or LACI immediately after hospital discharge.
- Age: Between 35 and 85 years.
- Technology access: Ownership of a smartphone with Android operating system and internet access.
- Language skills: Ability to read, write, and understand instructions in Spanish, or the presence of a caregiver who can perform these tasks on behalf of the patient.
- Motor impairment: Minimal motor sequelae, defined by:
- "Timed Up and Go" (TUG) test: In less than 13.5 seconds.
Show all 9Show fewer
- Score of 3-5 points on the Functional Ambulatory Category (FAC).
- Walking capacity: Ability to walk independently for 500 meters without technical or physical assistance.
- Spasticity: Minimal or absent spasticity (score of 0-1 on Ashworth Scale
Who cannot join
- Oxygen dependency: Dependency on auxiliary oxygen.
- Uncontrolled or unstable conditions: Including angina pectoris, hypertension (defined as resting systolic blood pressure >180 mm Hg and diastolic >110 mm Hg), arrhythmias (atrial/ventricular), sinus tachycardia (heart rate >120/min), and diabetes mellitus.
- Orthostatic hypotension: Drop in blood pressure >20 mm Hg with associated symptoms.
- Significant aortic stenosis: Defined as a diameter <1 cm², or aortic dissection.
- Uncompensated cardiac failure: Including third-degree atrioventricular block without a pacemaker, active myocarditis/pericarditis, and atrial fibrillation.
- Recent embolism: Pulmonary or systemic embolism, or acute thrombophlebitis.
Show all 10Show fewer
- Systemic illness or fever: Presence of acute systemic disease or fever.
- Musculoskeletal conditions: That prevent participation in the therapeutic exercise program.
- Other metabolic conditions: Such as acute thyroiditis, hypo/hyperkalemia, and hypovolemia (until treated).
- Severe psychological disorders: Diagnosed severe psychological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephysical Therapy as a Secondary Stroke Prevention Tool
This study investigates the effectiveness of telephysiotherapy as a rehabilitation and secondary prevention tool in patients with minor stroke, TIA, or LACI, comparing an experimental group receiving tele-assisted aerobic and anaerobic exercises to a control group.
Read the detailed description
Stroke is an acute disorder of cerebral blood flow that can cause transient or permanent alterations in the functionality of the brain, often resulting from ischemia or hemorrhage. Depending on the affected region and its severity, strokes range in impact, with minor strokes characterized by mild symptoms. Despite the potential for rapid symptom improvement in transient ischemic attacks (TIAs), both minor strokes and TIAs significantly impact long-term quality of life.
The implementation of physical rehabilitation, particularly through structured exercise, is critical for mitigating motor deficits, reducing fatigue, and improving functional capabilities post-stroke. Tele-physical therapy (TPT)/Therapeutic Tele-Assisted Exercise (T-TEx/T-FIS) has emerged as a promising approach for delivering rehabilitation remotely, offering convenience and ensuring continuity of care while addressing limitations posed by traditional in-person therapy. Recent systematic reviews suggest that TPT/T-TEx/T-FIS demonstrates comparable outcomes to conventional physiotherapy, highlighting its potential for wider adoption.
The hypothesis is that a 12-week tele-physiotherapy program can significantly improve cardiovascular health, reduce obesity, and enhance quality of life in patients with minor stroke, TIAs, or lacunar infarcts, compared to standard lifestyle recommendations alone. The primary objective is to evaluate the efficacy of tele-physiotherapy in addressing modifiable risk factors for secondary stroke prevention. Secondary goals include analyzing improvements in cardiorespiratory fitness, muscle strength, sleep quality, and fatigue, while promoting healthy lifestyle habits and tracking adherence to therapeutic exercise.
A single-blind, randomized controlled trial is proposed, wherein patients are divided equally into a control group and an experimental group receiving TPT. Participants will undergo assessments at baseline, 4 weeks, and 12 weeks, with a follow-up at 24 weeks to evaluate sustained benefits.
- Conditions
- Stroke, Physical Therapy Modality, Secondary Prevention, Physical Therapy Evaluation, Therapeutic Exercise, Randomized Controlled Trial
- Being tested
- Telephysical therapy, Educational session
- Keywords
- Ischemic Attack, Transient, Brain Ischemia, Telephysical Therapy, Exercise Therapy, Neurological Disorders, Wearable Electronic Devices, Quality of life
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Brain Ischemia, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephysical therapyBehavioural
The experimental group is undergoing a tele-assisted therapeutic exercise program (T-TPT/T-FIS), which involves physical exercises aimed at improving cardiovascular fitness, muscle strength, and balance, among others. Participants will complete exercises under virtual supervision and submit progress reports.
Educational sessionBehavioural
The educational session will focus on raising awareness about stroke risk factors, such as hypertension, diabetes, and smoking, while promoting healthy lifestyle changes. The goal is to empower them with the knowledge to reduce stroke risk and improve overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| Telephysical therapy group with educational session | Experimental | The intervention includes 12 weeks of therapeutic exercise delivered via tele-assistance. Participants will engage in aerobic and anaerobic activities focusing on cardiovascular fitness, muscle strength, and balance. A recorded educational session will provide uniform information on the protocol, including schedules and intervention details. Patients will complete prescribed exercises under virtual supervision and submit progress reports for monitoring adherence. Receives: Behavioral: Telephysical therapy; Behavioral: Educational session |
| Educational session with encouraged lifestyle modifications | Active comparator | The control group will be encouraged to return to their regular daily activities and engage in exercise. Evaluations will be scheduled and communicated to participants. The control group will not receive direct intervention. Receives: Behavioral: Educational session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (SF-36)
Assessed using the SF-36 questionnaire, which evaluates physical and mental health domains. The scale consists of 36 questions, assesing physical function (10 items), physical role (4 items), bodily pain (2 items), general health status (5 items), vitality (4 items), social function (2 items), emotional role (3 items), mental health (5 items), and health transition (1 item). A higher score indicates better health status.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Gait characteristics (GAITRite system and 6MWT)
Assessed using the GAITRite system and the 6-minute walk test (6MWT). The GAITRite system will measure weight distribution, support surface, time in double support and single support, step time, step symmetry and length, and gait normality. Measurements will be taken while wearing shoes, both before and after performing the 6MWT. The 6-minute walk test (6MWT) is a validated test and is considered highly reliable for measuring gait in stroke patients. Additionally, its execution has been validated in environments with limited space (15 and 30 meters), making it easier to use. It will also allow us to assess the response to exertion, as well as the gait adjustments associated with fatigue.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Fall risk and functional mobility (TUG)
Asesssed using the Timed Up and Go (TUG) Test. It is a valid, reliable, and easy-to-administer fall risk test used to measure advanced functional mobility after a stroke. To perform this test, the patient must rise from a chair, walk three meters, and return to sit as quickly as possible.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Balance (BBS)
Assessed using the Berg Balance Scale (BBS), which is designed to evaluate balance and predict gait and fall risk. This scale complements the Timed Up and Go (TUG) test. It includes 14 tasks, with the patient's movement quality rated on a scale from 0 to 4. The maximum achievable score is 56/56.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Walking and assistance (FAC)
Assesed using the level of walking and assistance using the Functional Ambulation Classification (FAC) Scale . This scale evaluates the patient's walking capacity and the degree of support required, categorizing walking ability into six distinct levels.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Fatigue associated with stroke (FSS)
Assessed the level of fatigue related to the stroke using the Fatigue Severity Scale. It is a 9-item scale that captures the patient's subjective assessment of their fatigue and its impact on their life, with scores ranging from 1 to 7. The possible values range from 9 to 63, with a lower score indicating a better outcome.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Handgrip strength (Digital Dynamometer)
Measured to assess muscular strength and serves as a predictor of cardiovascular events, chronic diseases, and overall health. Studies highlight its predictive value. A digital dynamometer from the brand Vicfund will be used for its measurement.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Secondary outcomes (8)
Body mass index (BMI)
Weight and heigh will be combined to report Body Mass Index (BMI). While BMI is a useful health indicator for any patient, its influence on stroke has also been documented. Data will be collected using a tape measure and a scale. It will be recorded in kg/m^2.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Sagittal abdominal diameter (SAD)
Abdominal fat accumulation is a key component of the cardiometabolic syndrome, which is associated with stroke, heart attack, cardiovascular diseases, metabolic complications, and overall mortality. It has been shown that this risk increases when the diameter exceeds 25 cm. Data will be collected using a tape measure. It will be recorded in cm.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
VO2 peak
VO2 peak will allow us to assess cardiorespiratory health. It will be measured using a smartwatch while the patient is lying down, 5 minutes after exercise. It will be recorded in ml O2/kg/min.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Blood pressure
Blood pressure will be measured in a seated position before exertion, after exercise, and 5 minutes post-rest, using a smartwatch. The value will be recorded in mmHg.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Biochemical levels
These are considered the main modifiable risk factors for stroke recurrence. Blood lipid and glucose levels will be collected through biochemical analysis provided by the hospital's blood collection service. The sample will be taken on the same day as the evaluation, with analysis and result collection afterward. Patients should fast for a minimum of 8 to 12 hours before the extraction, as is also required for blood pressure measurement.
- Glucose: Measured in mg/dl, and consideration will be given to whether the patient has diabetes mellitus. Additionally, glycated hemoglobin will be recorded.
- Lipids: The following lipid parameters will be measured: LDL (low-density lipoprotein), HDL (high-density lipoprotein), total cholesterol, and triglycerides.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Adherence to therapy
Assessed through an online form. The patient will complete a daily Google form where they will record the values obtained from the smartwatch, alcohol, and tobacco consumption, as well as their subjective feelings of effort and rest. Adherence will be measured by the number of forms submitted throughout the study and the data provided in them.
Measured: Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).
Perceived exertion
To dose physical activity, understanding the sensation of exertion will allow us to program the workload more selectively for each patient. The Borg scale has proven useful for this purpose and is also easy for the patient to record. To use it, the patient simply needs to rate the level of fatigue associated with the exertion on a scale from 0 to 10.
Measured: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Harmful habits and sleep
Tobacco and alcohol consumption are recognized as risk factors for suffering from strokes. Therefore, it will be important to record this information to evaluate the evolution of the patient's habits and the impact of their consumption on other parameters. For measurement, the patient will manually record their consumption daily in a form, indicating "cigarettes consumed" and "glasses of alcoholic beverages."
The subjective quality of sleep in post-stroke patients is related to depression and affects physical functionality. To measure this, the patient will rate the quality of their rest on a scale from 0 to 10 in the form daily and will also record the number of hours of sleep monitored by the smartwatch.
Measured: Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start14 Jan 2025
- Primary completion31 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Responsible party
- Principal investigator, Ignacio Pastor Ruiz, University of Cadiz
- Investigators
- David Manuel Lucena Antón, Doctor of PT, Study director, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780891
- Sponsor's protocol ID
- 0616-N-22
- Acronym
- TPT-Stroke
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephysical Therapy as a Secondary Stroke Prevention Tool
- ClinicalTrials.gov ID
- NCT06780891
- Acronym / sponsor ID
- TPT-Stroke / 0616-N-22
- Conditions
- Stroke, Physical Therapy Modality, Secondary Prevention, Physical Therapy Evaluation, Therapeutic Exercise, Randomized Controlled Trial
- Keywords
- Ischemic Attack, Transient, Brain Ischemia, Telephysical Therapy, Exercise Therapy, Neurological Disorders, Wearable Electronic Devices, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 17 Jan 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 investigates the effectiveness of telephysiotherapy as a rehabilitation and secondary prevention tool in patients with minor stroke, TIA, or LACI, comparing an experimental group receiving tele-assisted aerobic and anaerobic exercises to a control group.
Detailed description
Stroke is an acute disorder of cerebral blood flow that can cause transient or permanent alterations in the functionality of the brain, often resulting from ischemia or hemorrhage. Depending on the affected region and its severity, strokes range in impact, with minor strokes characterized by mild symptoms. Despite the potential for rapid symptom improvement in transient ischemic attacks (TIAs), both minor strokes and TIAs significantly impact long-term quality of life.
The implementation of physical rehabilitation, particularly through structured exercise, is critical for mitigating motor deficits, reducing fatigue, and improving functional capabilities post-stroke. Tele-physical therapy (TPT)/Therapeutic Tele-Assisted Exercise (T-TEx/T-FIS) has emerged as a promising approach for delivering rehabilitation remotely, offering convenience and ensuring continuity of care while addressing limitations posed by traditional in-person therapy. Recent systematic reviews suggest that TPT/T-TEx/T-FIS demonstrates comparable outcomes to conventional physiotherapy, highlighting its potential for wider adoption.
The hypothesis is that a 12-week tele-physiotherapy program can significantly improve cardiovascular health, reduce obesity, and enhance quality of life in patients with minor stroke, TIAs, or lacunar infarcts, compared to standard lifestyle recommendations alone. The primary objective is to evaluate the efficacy of tele-physiotherapy in addressing modifiable risk factors for secondary stroke prevention. Secondary goals include analyzing improvements in cardiorespiratory fitness, muscle strength, sleep quality, and fatigue, while promoting healthy lifestyle habits and tracking adherence to therapeutic exercise.
A single-blind, randomized controlled trial is proposed, wherein patients are divided equally into a control group and an experimental group receiving TPT. Participants will undergo assessments at baseline, 4 weeks, and 12 weeks, with a follow-up at 24 weeks to evaluate sustained benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephysical therapy group with educational session | Experimental | Behavioral: Telephysical therapy, Behavioral: Educational sessionThe intervention includes 12 weeks of therapeutic exercise delivered via tele-assistance. Participants will engage in aerobic and anaerobic activities focusing on cardiovascular fitness, muscle strength, and balance. A recorded educational session will provide uniform information on the protocol, including schedules and intervention details. Patients will complete prescribed exercises under virtual supervision and submit progress reports for monitoring adherence. |
| Educational session with encouraged lifestyle modifications | Active comparator | Behavioral: Educational sessionThe control group will be encouraged to return to their regular daily activities and engage in exercise. Evaluations will be scheduled and communicated to participants. The control group will not receive direct intervention. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis: Subjects with a diagnosis of minor stroke, TIA, or LACI immediately after hospital discharge.
- Age: Between 35 and 85 years.
- Technology access: Ownership of a smartphone with Android operating system and internet access.
- Language skills: Ability to read, write, and understand instructions in Spanish, or the presence of a caregiver who can perform these tasks on behalf of the patient.
- Motor impairment: Minimal motor sequelae, defined by:
Key exclusion criteria (10 listed)
- Oxygen dependency: Dependency on auxiliary oxygen.
- Uncontrolled or unstable conditions: Including angina pectoris, hypertension (defined as resting systolic blood pressure >180 mm Hg and diastolic >110 mm Hg), arrhythmias (atrial/ventricular), sinus tachycardia (heart rate >120/min), and diabetes mellitus.
- Orthostatic hypotension: Drop in blood pressure >20 mm Hg with associated symptoms.
- Significant aortic stenosis: Defined as a diameter <1 cm², or aortic dissection.
- Uncompensated cardiac failure: Including third-degree atrioventricular block without a pacemaker, active myocarditis/pericarditis, and atrial fibrillation.
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 |
|---|---|---|
| Telephysical therapyThe experimental group is undergoing a tele-assisted therapeutic exercise program (T-TPT/T-FIS), which involves physical exercises aimed at improving cardiovascular fitness, muscle strength, and balance, among others. Participants will complete exercises under virtual supervision and submit progress reports. | Behavioural | Telephysical therapy group with educational session |
| Educational sessionThe educational session will focus on raising awareness about stroke risk factors, such as hypertension, diabetes, and smoking, while promoting healthy lifestyle changes. The goal is to empower them with the knowledge to reduce stroke risk and improve overall well-being. | Behavioural | Educational session with encouraged lifestyle modifications, Telephysical therapy group with educational session |
Primary outcome
Quality of life (SF-36)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Assessed using the SF-36 questionnaire, which evaluates physical and mental health domains. The scale consists of 36 questions, assesing physical function (10 items), physical role (4 items), bodily pain (2 items), general health status (5 items), vitality (4 items), social function (2 items), emotional role (3 items), mental health (5 items), and health transition (1 item). A higher score indicates better health status.
Gait characteristics (GAITRite system and 6MWT)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Assessed using the GAITRite system and the 6-minute walk test (6MWT). The GAITRite system will measure weight distribution, support surface, time in double support and single support, step time, step symmetry and length, and gait normality. Measurements will be taken while wearing shoes, both before and after performing the 6MWT. The 6-minute walk test (6MWT) is a validated test and is considered highly reliable for measuring gait in stroke patients. Additionally, its execution has been validated in environments with limited space (15 and 30 meters), making it easier to use. It will also allow us to assess the response to exertion, as well as the gait adjustments associated with fatigue.
Fall risk and functional mobility (TUG)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Asesssed using the Timed Up and Go (TUG) Test. It is a valid, reliable, and easy-to-administer fall risk test used to measure advanced functional mobility after a stroke. To perform this test, the patient must rise from a chair, walk three meters, and return to sit as quickly as possible.
Balance (BBS)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Assessed using the Berg Balance Scale (BBS), which is designed to evaluate balance and predict gait and fall risk. This scale complements the Timed Up and Go (TUG) test. It includes 14 tasks, with the patient's movement quality rated on a scale from 0 to 4. The maximum achievable score is 56/56.
Walking and assistance (FAC)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Assesed using the level of walking and assistance using the Functional Ambulation Classification (FAC) Scale . This scale evaluates the patient's walking capacity and the degree of support required, categorizing walking ability into six distinct levels.
Fatigue associated with stroke (FSS)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Assessed the level of fatigue related to the stroke using the Fatigue Severity Scale. It is a 9-item scale that captures the patient's subjective assessment of their fatigue and its impact on their life, with scores ranging from 1 to 7. The possible values range from 9 to 63, with a lower score indicating a better outcome.
Handgrip strength (Digital Dynamometer)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Measured to assess muscular strength and serves as a predictor of cardiovascular events, chronic diseases, and overall health. Studies highlight its predictive value. A digital dynamometer from the brand Vicfund will be used for its measurement.
8 secondary outcomes
Body mass index (BMI)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Sagittal abdominal diameter (SAD)
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
VO2 peak
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Blood pressure
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Biochemical levels
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Adherence to therapy
Time frame: Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).
Perceived exertion
Time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Harmful habits and sleep
Time frame: Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).
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 May 2025.
- Individual participant dataSharing planned: No
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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.
David Manuel Lucena Antón, Doctor of PT study director
University of Cadiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephysical therapy and Educational session in people with Stroke and Physical Therapy Modality, run by University of Cadiz 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 9 inclusion and 10 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 May 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 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?
Quality of life (SF-36) (time frame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).). The study lists 7 primary outcomes in all. 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 28 May 2025.