Rehabilitation study on Alzheimer’s disease

ISRCTN	ISRCTN69319888
DOI	https://doi.org/10.1186/ISRCTN69319888
Sponsor	Navy Qingdao Special Service Recuperation Center
Funder	Navy Qingdao Special Service Recuperation Center

Submission date: 17/03/2026
Registration date: 20/03/2026
Last edited: 17/03/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Changyao Zhang
Principal investigator, Public, Scientific

No. 27, Hong Kong West Road, Shinan District
Qingdao
266000
China

Phone	+86-0532-51885061
Email	zhangchangyao1@outlook.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Health services research
Scientific title	Effects of extended rehabilitation on the general cognition of patients with Alzheimer’s disease and the anxiety and sleep state of their families
Study objectives
Ethics approval(s)	Approved 31/05/2023, Ethics Committee of Navy Qingdao Special Service Recuperation Center (No. 27, Hong Kong West Road, Shinan District, Qingdao, 266000, China; +86 0532-51885078; -), ref: -
Health condition(s) or problem(s) studied	Rehabilitation study of Alzheimer's disease
Intervention	This study was an interventional study involving patients with Alzheimer's disease (AD) and their family members. A total of 63 patients were randomly stratified by age and divided into two groups using a random number table method: a control group (30 patients) and an experimental group (33 patients). Both groups received one month of inpatient rehabilitation, including routine medication, activities of daily living (ADL) training, cognitive exercises, environmental memory training, speech therapy, music therapy, and manual dexterity training. After discharge, the control group received no further guidance and was followed up for three months. The experimental group received an additional three months of extended rehabilitation at home or in a nursing home, guided by a designated contact person (usually a family member or caregiver) who followed a daily work plan provided by the hospital. The plan included daily ADL training and at least weekly cognitive and memory exercises. Nursing staff conducted weekly telephone follow-ups and bi-weekly home visits to monitor adherence and provide guidance. The intervention lasted three months post-discharge, with assessments conducted at baseline, 1 month, 2 months, and 3 months.
Intervention type	Behavioural
Primary outcome measure(s)	Cognitive function measured using the Montreal Cognitive Assessment (MoCA) scale at baseline, 1 , 2 and 3 months Activities of daily living measured using the Barthel Index for Activities of Daily Living (ADL) at baseline, 1 , 2 and 3 months Anxiety levels of family members measured using the Hamilton Anxiety Rating (HAM-A) scale at baseline, 1 , 2 and 3 months Sleep quality of family members measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline, 1 , 2 and 3 months
Key secondary outcome measure(s)
Completion date	31/12/2020

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	60 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	86
Total final enrolment	63
Key inclusion criteria	1. Montreal Cognitive Assessment Scale (MoCA) score was 10–25 points, which is in line with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for AD 2. Assessed using the Clinical Dementia Rating (CDR) scale as having mild, moderate, or severe dementia 3. Could understand, communicate with, and cooperate with investigators 4. In a stable condition without serious physical complications 5. Local to Qingdao and received care at home or in a nursing home after treatment
Key exclusion criteria	1. A type of dementia mentioned in the NINCDS-ADRDA diagnostic criteria that cannot be classed as AD, such as dementia with major vascular diseases or dementia caused by the use of drugs that affect cognition 2. Unable to be visited or followed up 3. Undergoing other drug trials
Date of first enrolment	01/01/2019
Date of final enrolment	11/01/2020

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan

Editorial Notes

17/03/2026: Study’s existence confirmed by the Ethics Committee of Navy Qingdao Special Service Recuperation Center, China.