Aerobic Trainings on Stroke Patients

NCT04135391 | Completed

• 1 other identifier: 201600576A3
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effects of different exercise strategies on stroke patients remain unclear. Randomized controlled trial with concealed allocation has been performed from August 1, 2016 to June 30, 2018. We traced back 23 stroke patients, recruited during the above period, aged about 55 years with stroke duration \> 24 months . Intervention: 13 of them underwent 36 times of moderate-intensity continuous training (MICT) at 60% of peak oxygen consumption (VO2peak) for 30 mins, and 10 had high-intensity interval training (HIIT) at alternative 80% and 40% VO2peak with the same training times and duration. Outcome measures: VO2peak, cardiac output (CO), bilateral frontal cortex blood volume (∆\[THb\]), oxyhemoglobin (∆\[O2Hb\]) and deoxyhemoglobin (∆\[HHb\]), ventilation efficiency, serum brain-derived neurotrophic factor (BDNF) levels, cognitive and life quality questionnaire, percentage of neuroblastic cell bearing neurites (% neurites), and cell fluorescent staining were examined before and after interventions.

Conditions

Stroke, Cardiovascular

Keywords

Stroke; Oxygen consumption; BDNF; Dendrites

Outcome Measures

Primary Outcomes (13)

• Peak cardiac output (CO)

  Peak CO in millimeter per minute measured by non-invasive cardiac output measurement during exercise test before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Peak exercise oxygen consumption (VO2peak)

  VO2peak in ml/min/kg measured by cardiopulmonary function test before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Oxygen uptake efficiency slope (OUES)

  OUES in liter per minute/log(Liter per minute) derived from oxygen consumptions along time during exercise test before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Ventilation/VCO2 ratio (Ve-VCO2)

  Ve-VCO2, a number, derived from exhaled CO2 (ml/min/kg) versus ventilation (ml/min/kg) graph along time during exercise test before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Differences of the brain tissue oxyhemoglobin (∆[O2Hb])

  Differences oxyhemoglobin between involved and uninvolved frontal cortices in μM measured by two pairs of near infra-red spectroscopy (NIRS) probes before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Differences of the brain tissue deoxygenation (∆[HHb])

  Differences deoxyhemoglobin between involved and uninvolved frontal cortices in μM measured by two pairs of near infra-red spectroscopy (NIRS) probes before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Differences of regional blood volume (∆[THb])

  Differences regional blood volume between involved and uninvolved frontal cortices in μM measured by two pairs of near infra-red spectroscopy (NIRS) probes before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Physical component score (PCS)

  Physical role function obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  3-4 months (for 36 times of exercise training)

• Mental component score (MCS)

  Mental health score obtained from short form 36 questionnaire (SF-36) before and after exercise training. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  3-4 months (for 36 times of exercise training)

• Mini-mental status examination (MMSE)

  a 30-point questionnaire that is used extensively to measure cognitive impairment before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Brain-derived neurotrophic factor (BDNF)

  The human BDNF (ng/mL), essential in maintaining neurogenesis and synaptic plasticity, capture antibody in a solid-phase sandwich, two-site enzyme linked immunoassay (ELISA) kit. The BDNF level was then determined by the microplate reader before and after exercise training.

  3-4 months (for 36 times of exercise training)

• Percentage of cell bearing neurites

  A total of 100000 cells were plated overnight on 35-mm dishes coated with poly- DL-lysine. After serum starvation in DMEM containing 2% HS for 12-18 h, cells were treated with 50 ng/ml NGF for the indicated time. Morphological changes were observed using the Leica TCS SP8 confocal microscopy 7 days after cultured with patient sera before and after exercise training. Percentage of cells with neurites of at least one cell body diameter in length was determined in five independent fields of every plate.

  3-4 months (for 36 times of exercise training)

• Neuron images

  Cells (100000) were inoculated in each well of the eight-chamber slide (Millicell EZ slide, Millipore Corp., Billerica, MA) and were incubated at the pre- and post-MICT or HIIT sera for 12h. Vivid staining of Mitotracker (Invitrogen corp., Carlsbad, CA) was used to observe mitochondria in neuroblastic cells treated with sera from the above different status. The cells were stained with primary rabbit monoclonal anti-⍺-tubulin antibodies (Cell Signaling Technology Inc., Boston, MA). Fluorescein isothiocyanate-conjugated AffiniPure Goat anti-rabbit IgG (Jackson ImmunoResearch Laboratories, West Grove, PA) was used as the secondary antibody. Nuclei were counterstained with mounting medium (Vector Laboratories Inc., Burlingame, CA) containing 40,6-diamidino-2-phenylindole. The stained cells were examined with a confocal microscopic examination (Leica TCS SP8, Leica Microsystems Inc., Buffalo Grove, IL).

  3-4 months (for 36 times of exercise training)

Study Arms (1)

Pre- and Post- exercise training effects

EXPERIMENTAL

All recruited subjects received aerobic exercise training (HIIT or MICT). VO2peak, cardiac output (CO), bilateral frontal cortex blood volume (∆\[THb\]), oxyhemoglobin (∆\[O2Hb\]) and deoxyhemoglobin (∆\[HHb\]), ventilation efficiency, serum brain-derived neurotrophic factor (BDNF) levels, cognitive and life quality questionnaire, percentage of neuroblastic cell bearing neurites (% neurites), and cell fluorescent staining were examined before and after interventions.

Behavioral: Aerobic exercise training

Interventions

Aerobic exercise training BEHAVIORAL

All recruited subjects underwent 36 times of moderate-intensity continuous training (MICT) at 60% of peak oxygen consumption (VO2peak) for 30 mins, and 10or had high-intensity interval training (HIIT) at alternative 80% and 40% VO2peak with the same training times and duration.

Pre- and Post- exercise training effects

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke patients, diagnosed by the neurologist, with stable clinical status for greater than 3 months after conservative treatment or intervention were enrolled in the study.
• Mini-mental state examination (MMSE)\> 24
• No acute coronary syndrome

You may not qualify if:

• Unstable angina
• Systolic blood pressure\> 200 mmHg or diastolic blood pressure\> 110 mm Hg
• Symptomatic orthostatic hypotension
• Severe aortic stenosis (peak systolic pressure gradient\> 50 mmHg, or an aortic valve opening area\< 0.75 cm2)
• Inflammatory disease within recent 3 months
• Uncontrolled cardiac dysrhythmias
• Uncompensated heart failure
• Pericarditis or myocarditis within recent 3 months
• Embolic disease within recent 3 months
• ST segment displacement≥ 2 mm at rest
• Uncontrolled diabetes (blood glucose≥ 300 mg/dL or ≥ 250 mg/dL with ketone bodies).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (1)

• Hsu CC, Fu TC, Huang SC, Chen CP, Wang JS. Increased serum brain-derived neurotrophic factor with high-intensity interval training in stroke patients: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101385. doi: 10.1016/j.rehab.2020.03.010. Epub 2020 May 11.

  PMID: 32344098 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial was performed in stroke patients adequate for exercise trainings. Different exercise regimens were prescribed and was blind to the assessors. The study was conducted from August 2016 to June 2018. Participants were randomly allocated to the moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT) groups using a computer-generated, concealed allocation schedule. All included stroke patients received traditional rehabilitation programs, including balance, range of motion, or therapeutic exercise, and additional in-hospital supervised 30 min of MICT or HIIT for 36 times. Data were collected by a blinded assessor prior to randomization after completing the exercise trainings.

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 22, 2019
• Study Start: August 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share