Clinical trial NCT06458348: Local Opera Viewing Combined Medical Gymnastics for Elderly PSCI
Official title: Construction and Empirical Study of Local Opera Appreciation Combined With Medical Gymnastics Training Program for Elderly Patients With Post-stroke Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke Cognitive Impairment
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: local opera viewing combined medical gymnastics for elderly PSCI

Detailed description: Cognitive impairment and hemiplegia are the two major problems faced by elderly patients with cognitive impairment after stroke. The application of local drama viewing and combined medical gymnastics training aims to improve sports and cognitive function. Local drama viewing and medical gymnastics training integrates drama art cognition and medical sports, is a beneficial scientific attempt.

To construct a local opera viewing combined medical gymnastics training program for elderly patients with post-stroke cognitive impairment, and to explore its feasibility, acceptability and safety.

Eligibility criteria: Inclusion Criteria:

Stroke patients who were hospitalized in the Department of Neurology of Zhangzhou Hospital and met the PSCI diagnostic criteria of the Expert Consensus on the Prevention and Treatment of Cognitive Impairment after Stroke in China were the subjects of the study. ① Stroke patients confirmed by neuroimaging, onset time within 1 week; (2) Cognitive impairment occurs after stroke events; ③ The scores of the simple mental state examination scale were points in the illiterate group, points in the primary school group, points in the secondary school group, and points in the college group; ④ can maintain independent sitting position ≥30 min; ⑤ Age ≥60 years old; ⑥ Volunteer to join the study and receive intervention treatment.

Exclusion Criteria:

* Other causes affect or lead to cognitive impairment, such as consciousness disorder, malignant tumor, severe liver and kidney insufficiency; ② There are serious cardiopulmonary and other systemic diseases; Visual or hearing impairment; ④ have emotional behavior abnormalities and mental illness (including depression); ⑤ A history of alcohol or drug abuse

Primary outcomes:
measure: NIH stroke scale, NIHSS
timeFrame: Before and at 3 months after the intervention
measure: Muscle strength
timeFrame: Before and at 3 months after the intervention
measure: Montreal cognitive assessment, MoCA-Beijing
timeFrame: Before and at 3 months after the intervention
measure: Mini-Mental State Examination, MMSE
timeFrame: Before and at 3 months after the intervention
Secondary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: Before and at 3 months after the intervention
measure: Hamilton Depression Rating Scale
timeFrame: Before and at 3 months after the intervention
measure: Pittsburgh Sleep Quality Index
timeFrame: Before and at 3 months after the intervention
measure: Stroke Impact Scale，SIS
timeFrame: Before and at 3 months after the intervention
measure: Subscales of the Functional Assessment of Communication Skills, SFACS
timeFrame: Before and at 3 months after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Zhangzhou Municipal Hospital
name: Biyun Xiao, MSc
role: PRINCIPAL_INVESTIGATOR
References: