Clinical trial NCT06401837: Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients
Official title: Circadian Based Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients Undergoing Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Cytokine
Circadian Rhythm
Acupressure
Post-stroke Fatigue
Sleep
Ischemic Stroke
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2024-05-07
Enrollment: 78
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25\~85% of first stoke patients had PSF in the first year. Literature review from animal studies suggested the mechanism of post-stroke fatigue may be due to prolonged production of inflammatory cytokines process after stroke. Acupuncture therapy which regulates the inflammatory process may have the potential to ameliorate fatigue symptoms alone with sleep disturbance after stroke. Acupressure which stimulating the same acupoints by manually pressure may make it easy to perform in anytime and anywhere. The effect of circadian based acupressure application on post-stroke fatigue and sleep disturbances need be further examined. The purpose of this two-year study is to

(1) explore the distribution of inflammatory cytokines (blood and urine IL-1β, IL-6, TNF-α, IL-8) and post-stroke fatigue and sleep, and (2) examine the effect of circadian-based acupressure application on the inflammatory cytokines (urine and blood IL-1β, IL-6, TNF-α, IL-8), and post-stroke symptoms fatigue and sleep) in ischemic stroke patients with post-stroke fatigue during rehabilitation. Ischemic stroke patients (N=240) will be assessed from the rehabilitation wards.

Patients with fatigue (FAS\>=24) at assessment (n=78) will be further randomly assigned to the circadian based acupressure application group (AA), or the routine care control group (RC) for 2 weeks. Data of inflammatory cytokines (of IL-1β, IL-6, TNF-α, IL-8), post-stroke fatigue (Fatigue assessment scale), and sleep (Pittsburg Sleep Quality Index and consumer tracker) will be collected. Descriptive statistics, t-test, repeated measure ANOVA, linear/logistic regression or appropriate nonparametric equivalent will be used to compare pre-post differences and to compare differences between groups. Study results will provide information about the mechanism and effect of acupressure application on inflammation and post-stroke fatigue and sleep disturbances in ischemic stroke patients.

Detailed description: This is a two-year project. Two groups, randomized controlled experimental design, will be used to examine the effects of circadian-based acupressure application on inflammatory cytokines and post-stroke symptoms (fatigue and sleep) in ischemic stroke patients with fatigue (Figure 3). Ischemic stroke patients with fatigue (FAS \>=24) during the first 6 months of rehabilitation, who were screened from the primary assessment, will be randomly assigned to two groups: the circadian-based acupressure application group (AA ) and the routine care control group (RC). Each patient will receive a 2-week intervention according to their group.

Acupressure application (AA) group Patients in the AA group will have the circadian-based acupressure application twice a day, 5 days per week for 2 weeks. Acupressure application will be performed in the morning after one hour of breakfast and in the evening 12 hours before bedtime by a nurse well-trained in Chinese medicine nursing during the first week. Acupoints include three points in hand: PC6, LI4 Hegu, HT7 Shenmen; two points in leg: SP6 Sanyinjiao \& ST36 Zusanli; and one point in back: DU14 Dazhui will be selected. The nurse will also teach patients and their caregivers how to apply acupressure on these acupoints. Self-administered acupressure application on the above acupoints will be performed and followed in the second week. A rehabilitation program and routine care will be scheduled as usual except for acupressure. During nighttime, ambient light will remain dark or dim (\<30 lux). Education programs for circadian-based lifestyle and acupressure applications will be provided to patients and caregivers.

Routine care control (RC) group: Patients in the RC group will get routine care as usual for rehabilitation. The ambient light at night will also keep as dark or dim (\<30 lux). The same education program for a circadian-based lifestyle as the AA group will also be provided to patients and caregivers.

Outcomes of inflammatory cytokines, post-stroke fatigue, and sleep will be compared during(the 1st week) and after intervention (2nd week) between groups.

Eligibility criteria: Inclusion Criteria:

1. Ages 50 years old and above, both sex.
2. Diagnosed with stroke, ischemic.
3. Consciousness clear (GCS\>=13)
4. Stable vital signs and neurological functional status with no or controlled complications (e.g., infection or gastrointestinal bleeding).
5. With fatigue (FAS \>=24)

Exclusion Criteria:

1. Severe cognition impairment unable to give consent
2. Dysphasia
3. Ventilation use
4. Multiple diseases with unstable conditions
5. Receiving acupuncture therapy with the same acupoints.

Primary outcomes:
measure: Inflammatory cytokines
timeFrame: 10 cc of urine sample in the morning will be collected from each patient at baseline, and after 2 weeks of intervention.
measure: Sleep
timeFrame: Patients wear a consumer tracker at baseline, 1st week during intervention, and after 2nd weeks of intervention for 24 hours each.
measure: Sleep quality
timeFrame: Patients will fill out the PSQI questionnaire at baseline, 1st week during intervention, and after 2nd weeks of intervention.
measure: Fatigue.
timeFrame: Patients will be measured at baseline, 1st weeks during intervention, and after 2nd weeks of intervention.
Secondary outcomes:
measure: Depression
timeFrame: Participants will be assessed by the GDS-15 at baseline. Depression will serve as a covariate in this study.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital Taichung East Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: