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Dance/Movement Therapy for Bone Mineral Density in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dance/movement therapy
treatment as usual
Sponsored by
Beijing HuiLongGuan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

40 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 1) a diagnosis of SZ using the DSM-V; 2) 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; 3) ability to understand Mandarin Chinese; 4) legally eligible to sign an informed consent form; 5) current antipsychotic medication stability for more than 2 years; 6) reduced bone mass, osteoporosis, and severe osteopenia after bone density analysis; 7) no comorbid serious physical illness and physical impairments and can cooperate with nurses to complete the general intensity of activity training and 8) 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; and 4) lower limb injury and motor dysfunction, and inability to complete DMT intervention for various reasons. -

Sites / Locations

  • DMT

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dance/movement therapy (DMT), twice a week, 12 weeks,

Treatment as usual (TAU), twice a week, 12 weeks,

Arm Description

The multiple-session DMT intervention was applied to participants twice a week as a total of 24 sessions of 60 minutes over three months. The DMT intervention protocol was developed based on the therapist's experience, the theoretical frameworks, and the DMT approach described in a previous study (Bryl and Goodill 2019).

The TAU group sessions were conducted by the licensed professional employed at the hospital. 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

panss
THE POSITIVE AND NEGATIVE SYNDROME SCALES

Full Information

First Posted
January 29, 2023
Last Updated
January 29, 2023
Sponsor
Beijing HuiLongGuan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05716802
Brief Title
Dance/Movement Therapy for Bone Mineral Density in Schizophrenia
Official Title
Dance/Movement Therapy for Improving Bone Mineral Density in Long-term Patients With Schizophrenia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
January 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing HuiLongGuan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Schizophrenia (SZ) is a chronic, severe psychiatric disorder that affects approximately 1% of the population (Barnett 2018). 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 (Brekke et al., 2005). Moreover, individuals with SZ usually have higher disability and premature mortality rates compared to the general population (McCutcheon et al., 2020). Falls are a common concern in hospital settings, with studies reporting a fall rate between three and five falls per 1000 bed days (Healey et al., 2008; Oliver et al., 2010; Pham et al., 2022).Osteoporosis and its precursors, e.g. osteopenia and low bone mineral density (BMD), have been reported in chronic patients with SZ (Kishimoto et al., 2012; Stubbs et al., 2014; Gomez et al., 2016; Cui et al., 2018) and were strong predictors for subsequent falls and fractures in psychiatric hospitals (Stubbs et al. 2015; Stubbs et al., 2018). Dance/movement therapy (DMT), as one of the creative arts therapies (Millard et al., 2021), is an emerging therapy for the rehabilitation of patients with SZ in recent years (Xia and Grant 2009; Ren and Xia 2013; Millman et al., 2021; Wu et al., 2022). 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 (de Witte et al., 2021). The patients share their emotions, concerns, and coping strategies with others through dance/movement (Biondo et al., 2021; Bryl et al., 2022). 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 (Millman et al. 2021). In particular, a few studies have reported a critical role of DMT intervention in negative symptoms in chronic patients with SZ (Röhricht and Priebe 2006; Priebe et al., 2016). 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, we 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. We also examined whether DMT intervention can significantly change BMI, the levels of lipid profile, and serum calcium in patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dance/movement therapy (DMT), twice a week, 12 weeks,
Arm Type
Active Comparator
Arm Description
The multiple-session DMT intervention was applied to participants twice a week as a total of 24 sessions of 60 minutes over three months. The DMT intervention protocol was developed based on the therapist's experience, the theoretical frameworks, and the DMT approach described in a previous study (Bryl and Goodill 2019).
Arm Title
Treatment as usual (TAU), twice a week, 12 weeks,
Arm Type
Placebo Comparator
Arm Description
The TAU group sessions were conducted by the licensed professional employed at the hospital. 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).
Intervention Type
Behavioral
Intervention Name(s)
dance/movement therapy
Intervention Description
dance/movement therapy plus treat as usual
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Intervention Description
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).
Primary Outcome Measure Information:
Title
Bone mineral density measurement
Description
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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
panss
Description
THE POSITIVE AND NEGATIVE SYNDROME SCALES
Time Frame
week 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) a diagnosis of SZ using the DSM-V; 2) 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; 3) ability to understand Mandarin Chinese; 4) legally eligible to sign an informed consent form; 5) current antipsychotic medication stability for more than 2 years; 6) reduced bone mass, osteoporosis, and severe osteopenia after bone density analysis; 7) no comorbid serious physical illness and physical impairments and can cooperate with nurses to complete the general intensity of activity training and 8) 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; and 4) lower limb injury and motor dysfunction, and inability to complete DMT intervention for various reasons. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hengyong Guan, Dr.
Organizational Affiliation
Hebei Province Veterans Hospital
Official's Role
Study Director
Facility Information:
Facility Name
DMT
City
Baoding
State/Province
Hebei
ZIP/Postal Code
050899
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Dance/Movement Therapy for Bone Mineral Density in Schizophrenia

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