Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline

NCT03230253 | Completed DMC

• 1 other identifier: KMUHIRB-F(II)-20170040
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive and physical functions, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two hybrid interventions using the functional magnetic resonance imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

Conditions

Stroke Patients With Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• fMRI (change is being assessed)

  Resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).

Secondary Outcomes (22)

• Serum BDNF level

  Baseline, posttest (an expected average of 3 months)

• Antioxidative marker

  Baseline, posttest (an expected average of 3 months)]

• Glucose indicator

  Baseline, posttest (an expected average of 3 months)

• Plasma lipid level

  Baseline, posttest (an expected average of 3 months)

• Montreal Cognitive Assessment (MoCA)

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Study Arms (3)

Sequential training group

EXPERIMENTAL

Exercise training for 30 minutes followed by 30 minutes of cognitive-based intervention

Behavioral: Sequential training

Dual training group

EXPERIMENTAL

Exercise training simultaneously combined cognitive-based intervention for 60 minutes

Behavioral: Dual training

Control training group

ACTIVE COMPARATOR

non-aerobic exercise (e.g., stretch, range of motion exercise...) and unstructured cognitive rehabilitation programs (e.g., reading newspapers, playing board games...) for 60 minutes

Behavioral: Control training

Interventions

Sequential training BEHAVIORAL

The participant will cycle on a stationary bike for 30 minutes, which includes a 3-min warm-up phase followed by the aerobic training components (25 minutes), then a 2-min cool-down phase. The target heart rate during the aerobic training phase will be 40 to 70% of maximal heart rate (HRmax). After cycling, the participant will engage in a 30-minute of computer-based cognitive training program using BrainHQ (Posit Science Inc., San Francisco, CA, USA). The following are the areas of training: visuospatial processing, attention, memory, language, and logical thinking.

Sequential training group

Dual training BEHAVIORAL

The dual-task training group will cycling concurrently with the computer-based cognitive training. The training principle of cycling and cognitive training is similar to the SEQ group; however, the training intensity will be adjusted according to each participant's ability.

Dual training group

Control training BEHAVIORAL

The control participants will receive 60 minutes of health-related rehabilitation programs which involves non-aerobic physical exercise (e.g., muscle stretching, range of motion exercises, relaxation techniques) and unstructured cognitive related rehabilitation programs (e.g., watch health-related videos or read newspapers or magazines and then answer the content-related questions raised by the therapist).

Control training group

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 occurring at least 6 months prior to enrollment
• Age range from 20 to 80 years
• MMSE score \< 28 or MoCA\<25
• Able to follow the study instruction
• Adequate cardiopulmonary function to perform aerobic exercise
• Able to walk with or without assistive devices

You may not qualify if:

• Unstable medical history (e.g., recent myocardial infarction) that might limit participation
• Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
• Current participation in another interventional trial
• Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers, et al)
• Pregnant woman

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, 812, Taiwan

Location

Related Publications (2)

• Yeh TT, Chang KC, Wang JJ, Lin WC, Wu CY. Neuroplastic Changes Associated With Hybrid Exercise-Cognitive Training in Stroke Survivors With Mild Cognitive Decline: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 Sep;37(9):662-673. doi: 10.1177/15459683231200220.

  PMID: 37750660 DERIVED

• Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

  PMID: 35349186 DERIVED

Study Officials

• Ching-yi Wu, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 26, 2017
• Study Start: April 19, 2018
• Primary Completion: July 3, 2020
• Study Completion: July 31, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-09

Locations

TW (1)