Telephysical Therapy as a Secondary Stroke Prevention Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Cadiz
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Quality of life (SF-36)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Telephysical therapy group with educational session
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.
Intervention: Telephysical therapy (Behavioral)
Telephysical therapy group with educational session
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.
Intervention: Educational session (Behavioral)
Educational session with encouraged lifestyle modifications
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.
Intervention: Educational session (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Blood pressure(Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).)
- Body mass index (BMI)(Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).)
- Sagittal abdominal diameter (SAD)(Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).)
- VO2 peak(Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).)
- Biochemical levels(Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).)
- Adherence to therapy(Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).)
- Perceived exertion(Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).)
- Harmful habits and sleep(Daily throughout the duration of the study (from baseline (week 1) to post-intervention 2 (week 24)).)
Investigators
Ignacio Pastor Ruiz
Principal Investigator
University of Cadiz