SchizophreniaNCT05716802
Dance/Movement Therapy for Bone Mineral Density in Schizophrenia
A study testing dance/movement therapy and treatment as usual in people with Schizophrenia, run by Hebei Province Veterans Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- dance/movement therapy and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2020to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dance/Movement Therapy for Improving Bone Mineral Density in Long-term Patients With Schizophrenia: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Schizophrenia
- Being tested
- dance/movement therapy, treatment as usual
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dance/movement therapyBehavioural
dance/movement therapy plus treat as usual
treatment as usualBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Secondary outcomes (1)
panss scale
THE POSITIVE AND NEGATIVE SYNDROME SCALES. The minimum and maximum values are 28 and 198. Higher scores mean a worse outcome
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start7 Jul 2020
- Primary completion12 Jan 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Province Veterans Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hengyong Guan, Hebei Province Veterans Hospital
- Investigators
- Hengyong Guan, Dr., Study director, Hebei Province Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716802
- Sponsor's protocol ID
- xmh123
- Status last verified
- Mar 2024
- First submitted
- 29 Jan 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance/Movement Therapy for Improving Bone Mineral Density in Long-term Patients With Schizophrenia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05716802
- Acronym / sponsor ID
- xmh123
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hebei Province Veterans HospitalOther government
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dance/movement therapy (DMT), twice a week, 12 weeks, | Active comparator | Behavioral: dance/movement therapyThe 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). |
| Treatment as usual (TAU), twice a week, 12 weeks, | Placebo comparator | Behavioral: treatment as usualThe 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). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dance/movement therapydance/movement therapy plus treat as usual | Behavioural | dance/movement therapy (DMT), twice a week, 12 weeks, |
| treatment as usualThe 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). | Behavioural | Treatment as usual (TAU), twice a week, 12 weeks, |
Primary outcome
Bone mineral density measurement
Time frame: week 12
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.
1 secondary outcome
panss scale
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Schizophrenia
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
RecruitingObservational study
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Schizophrenia
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
Schizophrenia
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hengyong Guan, Dr. study director
Hebei Province Veterans Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dance/movement therapy and treatment as usual in people with Schizophrenia, run by Hebei Province Veterans Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density measurement (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.