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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05716802
Other study ID # xmh123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2020
Est. completion date July 12, 2022

Study information

Verified date March 2024
Source Hebei Province Veterans Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fractures are common accidents for long-term hospitalized patients with schizophrenia (SZ) in psychiatric hospitals, and once they occur, patients usually endure the pain of fractures for a long time. Accumulating evidence has supported implementing dance/movement therapy (DMT) as a promising intervention for patients with SZ. However, no study has been conducted to investigate its role in balance ability and metabolic parameters in SZ. This study was designed to investigate the treatment outcome of a 12-week DMT intervention on bone mineral density, balance ability, and metabolic profile in patients with SZ using a randomized, controlled trial design.


Description:

Schizophrenia (SZ) is a chronic, severe psychiatric disorder that affects approximately 1% of the population. The psychiatric symptoms and high rate of relapse of SZ can significantly impair cognitive and social functioning, including problem-solving skills, interpersonal relationships, and work performance. Moreover, individuals with SZ usually have higher disability and premature mortality rates compared to the general population. Falls are a common concern in hospital settings, with studies reporting a fall rate between three and five falls per 1000 bed days. Osteoporosis and its precursors, e.g. osteopenia and low bone mineral density (BMD), have been reported in chronic patients with SZ and were strong predictors for subsequent falls and fractures in psychiatric hospitals. Dance/movement therapy (DMT), as one of the creative arts therapies, is an emerging therapy for the rehabilitation of patients with SZ in recent years. DMT therapy uses dance activities and body movements to enhance well-being, mood, and quality of life. DMT therapy uses movement, dance, and interpersonal communication to explore a person's emotional, cognitive, social, and physical integration, enabling patients to enhance self-expression, accept and reconnect with their bodies, and strengthen their fitness. The patients share their emotions, concerns, and coping strategies with others through dance/movement. It can be applied to individuals of all ages, races, and genders and can be efficacious in individuals who experience losses in social, physical, and psychological functions. DMT has also been used to improve the cognition and social function of patients with mental diseases in psychiatric hospitals. In particular, a few studies have reported a critical role of DMT intervention in negative symptoms in chronic patients with SZ. However, there is still a lack of evidence that whether DMT is an effective therapy to increase the mean bone mineral density and reduce the risk of fractures due to falls in long-term hospitalized patients with SZ. In the present study, the investigators hypothesized that DMT intervention was effective to increase BMD and balance ability and decrease the metabolic parameters in long-term hospitalized male veterans with SZ as compared to the control group. They also examined whether DMT intervention can significantly change BMI, the levels of lipid profile, and serum calcium in patients.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 12, 2022
Est. primary completion date January 12, 2022
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of schizophrenia using the DSM-V; - male veterans, aged 40 to 60 years with a disease duration of 5 years or more and a long-term hospitalization of 3 years or more; - ability to understand Mandarin Chinese; - legally eligible to sign an informed consent form; - current antipsychotic medication stability for more than 2 years; - reduced bone mass, osteoporosis, and severe osteopenia after bone density analysis; - no comorbid serious physical illness and physical impairments and can cooperate with nurses to complete the general intensity of activity training; - consent for pre- and post-session interviews. Exclusion Criteria: 1) substance dependence or abuse; 2) hypercalcemia and hyperuricemia; 3) history of kidney stones or renal calculi; 4) lower limb injury and motor dysfunction, and inability to complete DMT intervention for various reasons. -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
dance/movement therapy
dance/movement therapy plus treat as usual
treatment as usual
The patients received regular daily antipsychotic medication and supportive psychotherapy once a week. They also participated in daily activities from Monday to Friday for at least two hours each day, including indoor activities (watching TV, playing games, playing poker) and outside activities (walking and doing radio gymnastics).

Locations

Country Name City State
China DMT Baoding Hebei

Sponsors (1)

Lead Sponsor Collaborator
Hebei Province Veterans Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone mineral density measurement The primary outcome measure was the BMD of patients recruited, which was assayed by an Erik AKDX-09W-1 bone density device (Shenzhen Ekere Electric Co.). The test was performed using the dual-energy X-ray absorptiometry method. Measurements were done at the distal end of the flexor bone of the patient's left forearm for fan beam and line scan, which were reviewed by an experienced radiologist who was blinded to the clinical and pharmacological characteristics and randomization of the patients. week 12
Secondary panss scale THE POSITIVE AND NEGATIVE SYNDROME SCALES. The minimum and maximum values are 28 and 198. Higher scores mean a worse outcome week 12
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