High-Intensity Interval Training in the Early Subacute Stroke With a Semi-recumbent Bike

NCT05804006 | Unknown DMC

• 1 other identifier: 0557CLERB-UP/P/SP/R/SA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Although High-intensity interval training (HIIT) exercise has emerged in recent years as a powerful time-efficient alternative to moderate-intensity continuous cardiovascular exercise training (MICT) to enhance neuroplasticity, motor, and cognitive functions, its feasibility remains to be determined early after stroke. Our study aims to investigate the feasibility of the HIIT program and its effects on functional abilities, cognitive function, and quality of life in early post-stroke.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (2)

• Feasibility aspects

  The feasibility aspects, include recruitment rates (eligible population / consented population x 100), program adherence (attended sessions / total number of sessions x 100), and the safety (percentage of participants who will experience adverse events)

  Up to 6 weeks

• The change in the credibility of the treatment and the expectations of the participants

  The treatment credibility and participant expectancy for improvement will be assessed with the Credibility and Expectancy Questionnaire (CEQ). The CEQ includes six items assessing a cognitively based credibility factor and an affectively based expectancy factor

  Week 1 and Week 6

Secondary Outcomes (7)

• Berg Balance Scale

  Week 1 and Week 6

• 5-Repetition Sit-To-Stand test

  Week 1 and Week 6

• modified Rankin Scale

  Week 1 and Week 6

• 6-min walk test

  Week 1 and Week 6

• 10 m walk test

  Week 1 and Week 6

Study Arms (1)

HIIT-REC

EXPERIMENTAL

High-intensity interval training program on a recumbent cycle SOLE R92 (HIIT-REC)

Other: Conventional physiotherapy followed by HIIT-REC program

Interventions

Conventional physiotherapy followed by HIIT-REC program OTHER

The experimental protocol will be preceded by 30 minutes of conventional physiotherapy followed by 15 min the rest period; then the HIIT-REC procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload at 50 rpm for weeks 1-2 and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (4 to 6 repetitions). The training intensity will progress similarly by 5% peak workload two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5

HIIT-REC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
• muscular weakness of the leg on the hemiplegic side defined as NIHSS-Item 6 score between 1 and 3;
• Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
• able to walk at least 5 meters independently with or without assistive devices and understand spoken instructions;
• living in Parakou or the surrounding area and wishing to undergo the program at the hospital.

You may not qualify if:

• Participants:
• unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate;
• cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy);
• primary orthopedic conditions (fractures, active rheumatoid arthritis);
• other neurological diseases such as (Parkinson's disease and Alzheimer's disease).

Sponsors & Collaborators

• Hasselt University: lead
• Université de Parakou: collaborator

Study Sites (1)

Faculty of Rehabilitation Sciences

Diepenbeek, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Oyene R Kossi, PhD

  University of Parakou

  STUDY DIRECTOR

• Thierry R Adoukonou, MD, PhD

  University of Parakou

  STUDY DIRECTOR

• Peter R Feys, PhD

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elogni R Amanzonwé, MSc

CONTACT

+22995607820; renaud.amanzonwe@uhasselt.be

Dominique Hansen, PhD

CONTACT

+32 497 87 58 66; dominique.hansen@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Rehabilitation/Exercise Physiology in Cardiometabolic Diseases

Model Details: Conventional physiotherapy followed by High-Intensity Interval training on the semi-recumbent bike

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: April 7, 2023
• Study Start: December 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)