NCT05716802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

January 29, 2023

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • panss scale

    week 12

Study Arms (2)

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

ACTIVE COMPARATOR

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).

Behavioral: dance/movement therapy

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

PLACEBO COMPARATOR

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).

Behavioral: treatment as usual

Interventions

dance/movement therapy plus treat as usual

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

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).

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

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DMT

Baoding, Hebei, 050899, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Hengyong Guan, Dr.

    Hebei Province Veterans Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

July 7, 2020

Primary Completion

January 12, 2022

Study Completion

July 12, 2022

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations