Clinical trial NCT06226779: Baduanjin Versus Brisk Walking for Cognition in Schizophrenia
Official title: Mindful Exercise Baduanjin Versus Brisk Walking for Cognitive Function in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Exercise
Condition
Keywords: schizophrenia, mindful exercise, exercise, cognition
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study intends to recruit participants with schizophrenia for the practice of Baduanjin, brisk walking, and health education after enrollment. The study also including a maintenance program. Cognitive and physical function assessments will be conducted before, after, and during follow-up tests. The research hypothesis posits that both Baduanjin and brisk walking will confer beneficial effects on various aspects of cognitive and physical functions.

Detailed description: Cognitive function deficits are core features in patients with schizophrenia. These deficits need active intervention to prevent functional decline. Baduanjin and brisk walking show promise as interventions in patients with schizophrenia. This study investigated the effects of Baduanjin exercise versus brisk walking in patients with schizophrenia.

This study will be a single-blind, 3-arm, parallel, randomized controlled trial.

A total of 120 patients with schizophrenia will be enrolled and randomly assigned to the Baduanjin group, brisk walking group or control group. The intervention group will practice Badunjin exercise. While participants in brisk walking group will receive brisk walking at the same duration. The controls will watch videos that are not aimed at improving physical exertion. Maintenance programs will also be conducted for participants to encourage practicing in exercise after intervention. All group will undergo evaluation at three time points: baseline, immediately after intervention and 4-week follow up after intervention. The primary outcome will be cognitive function and physical function. Secondary outcomes will include mood, sleep quality, and quality of live.

Eligibility criteria: Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to the DSM-5.
2. Who will be above 20-65 years of age .
3. Having a stable mental status without shift in medication and keep in same dose for at least one month.
4. Being able to walk independently for 50 meters.

Exclusion Criteria:

1. Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.
2. Visual or auditory impairment that precludes completion of assessment.
3. Acute psychosis requiring hospitalization.
4. Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.

Primary outcomes:
measure: Change score of the Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of 6-minute walk test
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of 30-second chair stand test
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of Timed up-and-go test
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of dual task Timed up-and-go test (manual)
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of dual task Timed up-and-go test (cognitive)
timeFrame: Baseline, immediate after treatment, 4-week follow up
Secondary outcomes:
measure: Change score of Depression, Anxiety Stress Scales-21 (DASS-21)
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change score of Pittsburg Sleep Quality Index
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change score of Euro-Qol 5-Dimmensions (EQ-5D).
timeFrame: Baseline, immediate after treatment, 4-week follow up
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung Medical Center
Study officials:
affiliation: Chang gung memorial hospital, Kaohsiung branch
name: Chen Chyi-Rong, Master
role: PRINCIPAL_INVESTIGATOR
References: