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

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

Interventions

DEVICE

Therapeutic exercise program combined with RMT

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.

DEVICE

Therapeutic exercise program combined with sham RMT

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.

Sponsors & Collaborators

• Complexo Hospitalario Universitario de A Coruña

  collaborator OTHER

• Universidade da Coruña

  collaborator OTHER

• Ana Lista Paz

  lead OTHER

Principal Investigators

• Ana Lista Paz, PhD · Faculty of Physiotherapy, University of A Coruña.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-30

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Spain

Study Locations