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Clinical Trials/NCT02550990
NCT02550990
Unknown
Not Applicable

Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline

Chang Gung Memorial Hospital6 sites in 1 country75 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Patients With Cognitive Decline
Sponsor
Chang Gung Memorial Hospital
Enrollment
75
Locations
6
Primary Endpoint
Change scores of Stroop Color-Word test
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
August 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
  • Age range from 20 to 90 years
  • MMSE score ≥ 19
  • Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
  • Able to follow the study instruction
  • Adequate cardiopulmonary function to perform aerobic exercise
  • Able to walk with or without assistive devices

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change scores of Stroop Color-Word test

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

Change scores of Montreal Cognitive Assessment (MoCA)

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

Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)

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

Change scores of Wechsler Memory Scale - Third Edition (WMS-III)

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

Change scores of Useful Field of View (UFOV)

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

Change scores of Dual-task test

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

The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.

Secondary Outcomes

  • Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of EuroQol (EQ)-5D questionnaire(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Rivermead Mobility Index (RMI)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Plasma lipid level(Baseline, posttest (an expected average of 3 months))
  • Change scores of serum BDNF level(Baseline, posttest (an expected average of 3 months))
  • Change scores of Antioxidative marker(Baseline, posttest (an expected average of 3 months))
  • Change scores of Caregiver Burden (CB) scale(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Functional Independence Measure (FIM)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Mobility level(Baseline, posttest (an expected average of 3 months))
  • Change scores of International Physical Activity Questionnaires (IPAQ)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Glucose indicator(Baseline, posttest (an expected average of 3 months))
  • Change scores of Fugl-Meyer Assessment (FMA)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Community Integration Questionnaire (CIQ)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Genotyping of the BDNF val66met polymorphism(Between baseline and posttest (an expected average of 3 months))
  • Change scores of Timed up and go test (TUG)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Six-minute walk test (6MWT)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Stroke Impact Scale (SIS)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of muscle strength(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
  • Change scores of Geriatric Depression Scale (GDS)(Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Study Sites (6)

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