Clinical trial NCT06780891: Effectiveness of Telephysical Therapy as a Secondary Stroke Prevention Tool in Patients With Minor Stroke.
Official title: Telephysical Therapy as a Secondary Stroke Prevention Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Physical Therapy Modality
Secondary Prevention
Physical Therapy Evaluation
Therapeutic Exercise
Randomized Controlled Trial
Cerebrovascular Accident (Stroke)
Keywords: Ischemic Attack, Transient
Brain Ischemia
Telephysical Therapy
Exercise Therapy
Neurological Disorders
Wearable Electronic Devices
Quality of life
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen Macarena
First posted: 2025-01-17
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Quality of life (SF-36)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Gait characteristics (GAITRite system and 6MWT)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Fall risk and functional mobility (TUG)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Balance (BBS)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Walking and assistance (FAC)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Fatigue associated with stroke (FSS)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Handgrip strength (Digital Dynamometer)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Sagittal abdominal diameter (SAD)
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: VO2 peak
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Blood pressure
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Biochemical levels
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Adherence to therapy
timeFrame: Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).
measure: Perceived exertion
timeFrame: Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).
measure: Harmful habits and sleep
timeFrame: Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: University of Cadiz
name: David Manuel Lucena Antón, Doctor of PT
role: STUDY_DIRECTOR
References: