Effectiveness of Therapeutic Exercise Combined With Respiratory Muscle Training in Patients With Subacute Stroke

NCT06949839 | Not Yet Recruiting

• 2 other identifiers: REMUST2025/061
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke has a significant impact on morbidity, mortality and healthcare expenditure globally. In addition to the motor and cognitive consequences, as well as on functional independence and social participation, it can produce alterations in the respiratory function. Scientific evidence supports the application of both therapeutic exercise programs and respiratory muscle training (RMT). However, studies that combine both interventions are limited, and to date no study has been published that examines the effectiveness of this combination in the subacute phase of stroke, which is the one that presents the widest range of neuroplasticity. Objectives: To analyze the effects of a combined therapeutic exercise and RMT program, compared to the therapeutic exercise and sham RMT program, on different variables related to functional, respiratory, swallowing and speech/voice capacity, in patients in the subacute phase of a stroke. Type of research: double-blind randomized controlled clinical trial. Design: The study will be carried out at the University Hospital Complex of A Coruña (CHUAC), where 64 patients with more than three and less than six months of evolution after a stroke will be recruited. Participants will be randomly assigned to two groups: the intervention group will perform a combined therapeutic exercise and RMT program, while the control group will combine the same therapeutic exercise program and sham RMT. The duration of the intervention will be eight weeks. The therapeutic exercise program will be carried out three days per week and will consist of a cardiovascular exercise part and a strength-endurance part. The RMT protocol will involve both the inspiratory and expiratory muscles, using the Orygen-Dual Valve® device. The control group will use the same valve but without resistance, generating a sham RMT. It will have a frequency of five days per week and will be carried out at the home of each patient. Additionally, half the subjects in the intervention group will continue the RMT protocol once the eight-week period has ended, with a frequency of two days per week, until the six-month follow-up. Possible differences between groups will be analyzed before and after the intervention, and at three and six months of follow-up, in relation to the following domains: functional capacity, functional independence, lung and respiratory muscle function, swallowing and speech/voice function, respiratory signs and symptoms, and quality of life.

Conditions

Stroke

Keywords

stroke; exercise therapy; respiratory muscle training; walk test; physical therapy modalities

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  The metric used to characterize the primary outcome measure will be the 6MWT. The 6MWT is a constant-load walking test that evaluates submaximal functional capacity. It consists of determining the distance a patient is able to walk at the maximum possible speed in six minutes, using standardized instructions. It will be carried out following the international standards of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). The test will be performed in a hallway, with two markers delimiting the 30-meter distance. Every minute during the test, oxygen saturation, heart rate (HR), and dyspnea and fatigue of the lower limbs will be recorded, and blood pressure (BP) will be measured both before and after the test. In the first assessment session, two attempts will be made due to the learning effect, separated by a 30-minute rest period or as long as necessary until vital signs recover. A single attempt will be made in subsequent measurements.

  The 6MWT will be assessed before the intervention, at the end of it (after 8 weeks) and at 3rd and 6th month of follow-up.

Secondary Outcomes (25)

• Sociodemographic data

  The personal interview will take place once, before the intervention.

• Anthropometrics

  Height, weight and BMI will be recorded in the first session (before intervention), and weight and BMI will be recorded in all assessment sessions (before and after intervention, and at the 3rd and 6th month of follow-up).

• Upper and lower limb motor function

  The MI will be assessed before the intervention, at the end of it (after 8 weeks) and at 3rd and 6th month of follow-up.

• Fall risk

  The TUG will be administered before the intervention, at the end of it (after 8 weeks) and at 3rd and 6th month of follow-up.

• Balance

  The BBS will be administered before the intervention, at the end of it (after 8 weeks) and at 3rd and 6th month of follow-up.

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group will perform a therapeutic exercise program combined with RMT

Device: Therapeutic exercise program combined with RMT

Control group

SHAM COMPARATOR

Control group will perform the same therapeutic exercise program combined with sham RMT

Device: Therapeutic exercise program combined with sham RMT

Interventions

Therapeutic exercise program combined with RMT DEVICE

For the RMT protocol, the Orygen-dual valve® device will be used. Each participant will start with a load of 30% of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Once every 10 days, the performance will be reviewed and the resistance will be increased by 10cmH2O of the initial MIP/MEP of each patient. Each session will consist of breathing through the device for 20 minutes (10 minutes dedicated to each muscle group). This process will be repeated once a day, five days a week, for eight weeks. The therapeutic exercise program will be common to both groups and will be carried out at CHUAC hospital, in group sessions. The sessions will be held three days a week, for eight weeks. Each session will consist of a 10-minute warm-up part, 45 minutes of the main part (aerobic and strength-resistance exercise), and five minutes of cooling down.

Intervention group

Therapeutic exercise program combined with sham RMT DEVICE

The sham RMT protocol will have the same frequency as in the intervention group. The therapeutic exercise program will be common to both groups and will be carried out at CHUAC hospital, in group sessions. The sessions will be held three days a week, for eight weeks. Each session will consist of a 10-minute warm-up part, 45 minutes of the main part (aerobic and strength-resistance exercise), and five minutes of cooling down.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those diagnosed with a first stroke occurring three to six months after the onset (subacute phase).
• Those aged 18 years or older.
• Those able to walk at least 10 meters, with or without walking aids and/or physical assistance from another person.

You may not qualify if:

• Those with recurrent stroke.
• Those with a history of chronic respiratory disease.
• Those with other underlying neurological diseases with impaired functionality prior to the stroke.
• Those with other cardiovascular or metabolic diseases in an unstable phase.
• Those with severe cognitive deficits that impede understanding of the assessment tests and/or the intervention.
• Those with severe facial paralysis that impedes proper performance of pulmonary function and respiratory muscle strength tests.
• Those with a prior participation in a RMT program.
• Those who participate in a cardiovascular and/or strength-endurance training program at the time of the study.
• Those with any of the contraindications to performing the tests included in the study protocol: spirometry, respiratory muscle strength and endurance tests, and 6MWT.
• Those with any of the contraindications to physical exercise.

Sponsors & Collaborators

• Ana Lista Paz: lead
• Complexo Hospitalario Universitario de A Coruña: collaborator
• Universidade da Coruña: collaborator

Study Sites (1)

University Hospital of A Coruña (CHUAC)

A Coruña, Spain

Location

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana Lista Paz, PhD

  Faculty of Physiotherapy, University of A Coruña.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Lista Paz, PhD

CONTACT

+34981167000; ana.lista@udc.es

Verónica Guerra Fandiño, PhD student

CONTACT

+34981167000; v.guerra@udc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, regardless of their group, will perform the same therapeutic exercise program. In addition, they will not know whether their RMT device is sham or not (they have the same appearance). One researcher (physical therapist) will perform both the outcomes assessment and the therapeutic exercise intervention and will be blinded to the group assignment of the patients to the intervention group or the control group. Another researcher (speech therapist) will be responsible for delivering the RMT and sham RMT devices based on the randomization and instructing the patients in their use, as well as increasing the resistance of the valve and re-evaluating the execution of the protocol to confirm that it is being carried out correctly. Therefore, this last therapist will be the only one who will know the group assignments. Mechanisms will be applied to verify whether the masking of both the physiotherapist and the patients to the groups has been violated at any time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD. Permanent Labor Professor of the Faculty of Physiotherapy at the University of Coruña

Model Details: Participants will be randomly assigned to two groups: the intervention group will perform a combined therapeutic exercise and RMT program, while the control group will combine the same therapeutic exercise program and sham RMT. The duration of the intervention (to both groups) will be eight weeks. The therapeutic exercise program will be carried out three days per week at the CHUAC hospital, and the RMT protocol will be carried out at the home of each patient five days per week, with on-site follow-up every 10 days at the CHUAC. Additionally, half of the subjects from the intervention group will continue the RMT protocol once the eight-week period has ended, with a frequency of two days per week and until the six-month follow-up.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 29, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)