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Efficacy of multimodal training with several types of exercises to increase walking ability and improve heart function in people affected by stroke

METCH: Multimodal exercise training Circuit with Higher-intensity approach to increase daily steps and reduce sitting time in stroke survivors: study protocol for a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2gf7h77
Enrollment
64
Registered
2024-03-13
Start date
2023-08-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

The present study is a randomized, single-blind clinical trial. To meet the methodological criteria, up to 64 volunteers will be included. The interventions will take place at the School Health Unit o
205m) and their age (= 60 years old or &gt
60 years old). The experimental group will engage in a multimodal exercise training circuit with higher-intensity, with heart rates tagged at 70-84% of maximum heart rate. In contrast, the control gro

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Irmandade Santa Casa de Misericórdia de São Carlos
Collaborator

Eligibility

Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Signed written informed consent; 40 - 80 years old; diagnosis of unilateral stroke between 6 up to 5 years before enrollment; ability to walk independently or with supervision and/or assistive devices; medical clearance for higher intensity exercise; preserved cognition, characterized by the ability to follow simple commands and to identify themselves in space and time; participants must be physically inactive, defined as <7,500 steps per day; participants must be willing and able to refrain from participation in any additional structured exercise or physical activity programs during the trial period

Exclusion criteria

Exclusion criteria: Cardiac surgery and/or acute myocardial infarction within one month; use a pacemaker; have obstructive or restrictive pulmonary disease; participants who withdraw their consent or experience severe symptoms during assessments or intervention; other neurological diseases

Design outcomes

Primary

MeasureTime frame
We expect to increase the daily steps (measured by ActiviPAL4TM micro). Assessments are made 15 days before the treatment, one week after the treatment, and six weeks after reassessment;We expect to improve the endothelium function (measured by Flow Mediated Dilatation brachial artery). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to improve cardiac function (left ventricular ejection). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment

Secondary

MeasureTime frame
We expect to improve the self-perceived assistance level, performance quality, and confidence (Lower Extremity Motor Activity Log). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to increase the walk endurance (6-minute walk test);We expect to improve the cardiac function (Transthoracic echocardiogram);We expect to reduce the carotid intima-media thickness (Carotid ultrasound);We expect to increase the heart rate variability (assessed by Polar and active postural change);We expect to improve the laboratory tests (assessed by collecting a blood sample);We expect to reduce the duration of Physical Inactivity (ActiviPAL4TM micro). Assessments are made 15 days before the treatment, one week after the treatment, and six weeks after reassessment ;We expect to reduce the sedentary behavior (ActiviPAL4TM micro). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to increase physical activity level (ActiviPAL4TM micro). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to improve the marching cadence (ActiviPAL4TM micro). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to improve the quality of Life (Stroke Specific Quality of Life Questionnaire). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to reduce sensorimotor impairment (Fugl-Meyer). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to improve the functional balance (Dynamic Gait Index and Timed Up and Go). Assessments are made 15 days prior to the treatment, one week after the treatment, and 6 weeks after reassessment;We expect to increase walking speed (Ten Meter Walk Test

Countries

BR

Contacts

Public ContactThiago de Russo

Universidade Federal de São Carlos

russo@ufscar.br+55-16-981172023

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 9, 2026