High Intensity Interval Training in Chronic Stroke Patients

NCT01777113 | Unknown DMC

• 1 other identifier: HIGHSTROKE-2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke is a global health-care problem that is common, serious and disabling. In most countries, stroke is second or third most common cause of death and one of the main causes of acquired adult disability. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. After completion of conventional physical therapy, there are no empiric recommendations and few resources promoting regular exercise during the chronic stroke period.Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.

Conditions

Stroke

Keywords

Chronic Stroke; Gait; Exercise; High intensity aerobic training; Strength training; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 6 minutes walking test (6-MWT)

  this is a validated tool evaluating walking capacity. Subjects will be required to walk at their maximum speed for 6 minutes and the score will be the covered distance.

  All patients enrolled in the study will be evaluated at baseline time 0 of treatment and after after 12 weeks of training.

Secondary Outcomes (12)

• 10 meters Walking test (10-MtWT)

  Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training

• Time Up and Go Test (TUG)

  Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training

• Gait analysis

  Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training

• Strength

  Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training

• Arterial - venous oxygen difference (a-v O2 diff)

  Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training

Study Arms (3)

High Intensity Aerobic training

EXPERIMENTAL

The subjects will perform a high intensity treadmill training

Other: High intensity aerobic training

High Intensity Strength Training

EXPERIMENTAL

The subjects will perform and high intensity training on the same leg horizontal press.

Other: High Intensity Strength Training

Mixed Training

ACTIVE COMPARATOR

Conventional training consisted of group mobility, balance and stretching exercises.

Other: Mixed Training

Interventions

High intensity aerobic training OTHER

The mode of the training will be uphill treadmill walking in 4x4 minute intervals at 85% and 95% of Heart Rate Peak (HRpeak) precede by 10-minute warm-up period on the treadmill at self-selected speed and inclination. Between the 4-minute intervals, 3-minute active breaks walking at approximately 50% of HRpeak will be applied. The training sessions will be terminated by a 3-minute cool-down period at 50% to 70% HRpeak. To compensate for increased VO2peak, the speed and/or inclination will be gradually adjusted during 3-month intervention to make sure that the target HR will be between 85% and 95% of HRpeak during the high-intensity intervals.

High Intensity Aerobic training

High Intensity Strength Training OTHER

Five warm-up repetitions will be completed at approximately 50% of 1 repetition maximum before the main session of four sets of four repetitions unilaterally at 85%Y95% of 1 repetition maximum for both leg press and plantarflexion. When subjects will be able to complete a fifth repetition, the weight will be increased by 1.25 to 2.5 kg, dependent on subjective feelings of capability. They will be encouraged to focus of an explosive concentric movement and a controlled eccentric movement such that the time on each phase will be in the ratio 1:2. The subjects will be regularly reminded to focus on breathing during the contraction, preventing the valsalva maneuver and high rises in blood pressure. The session will finish with a minimum 5-min warm down the treadmill device.

High Intensity Strength Training

Mixed Training OTHER

Conventional training consisted of group mobility, balance and stretching exercises. Mobility training included treadmill and cycloergometer training for 10 minutes at self selected speed. Exercises at the parallel bars included weight shift from leg to leg, half-squat, turn in place, leg-trunk flexion, and extension exercises. Finally seated upper- and lower-limb stretching exercises will focus on range of motion, including trunk mobility.

Also known as: Conventional Training

Mixed Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ischemical brain injury or intracerebral hemorrhage by MRI or computed tomography at least 6 months before the onset of the study;
• Ability to walk in the treadmill at \>0.3 km/h for 3 minutes handrail support;
• Be able to give informed consent and be motivated to participate in 3- month intensive physical fitness training.

You may not qualify if:

• Mini Mental State Examination \<20;
• Unstable angina pectoris;
• Unstable cardiac conditions;
• Complex ventricular arrhythmia;
• Resting systolic blood pressure \>200 mm/Hg - Resting diastolic blood pressure \>100 mm/Hg;
• Aphasia (unable to follow two commands);
• Other medical conditions precluding participation in aerobic exercise.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (2)

S.S.O. di Riabilitazione dell'Ospedale Policlinico

Verona, Italy, 37134, Italy

RECRUITING

S.S.O. di Riabilitazione dell'Ospedale Policlinico

Verona, Verona, 37134, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicola Smania, Physician

  Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Smania, Physician

CONTACT

+39 045 8124573; nicola.smania@univr.it

Daniele Munari, Master

CONTACT

+39 045 8124573; daniele.munari@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 28, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)