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Completed

NCT Number: NCT04071444

Exploring the Effects of a Baduanjin Program on the Symptoms of Constipation in Patients With Schizophrenia Spectrum

Patients with schizophrenia spectrum have been suffering from constipation due to long-term use of psychotropic medications and changes in physical activity and eating habits caused by diseases.

Aim this study was to examine the effectiveness of Baduanjin program in improving the symptoms of intestinal peristalsis and constipation in patients with psychosis.

Method:A randomized controlled trial was conducted in tow psychiatric centers in northern Taiwan.The experimental group was provided with an 8- session Baduanjin program for 24 weeks (1 hour, thrice times per week), while the control group received routine care.

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Key information

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, Taiwan

About this study

This study was conducted in two psychiatric center. Residents in one of psychiatric center were allowed to walk for 20 min after dinner every day, and each unit residents rare active. In this study, patients on the schizophrenia spectrum were invited to receive screening for constipation syndrome. A total of 275 patients agreed to undergo the screening. In total of 112 patients satisfied the inclusion criteria, and 58 patients consented to participate in the experiment.

Each participant was assigned one number from 1 to 112 by the first author. The second author enrolled participants. They were randomized to either Baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 3. Patients in the experimental group (EG) participated in the Baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 hour after dinner between 6 and 7 pm; the entire program continued for 24 weeks. The control group (CG) received routine care. The outcome indicators for this intervention program involved the risk factors for constipation, constipation symptoms, and Intestinal Peristalsis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Comply with the diagnosis of the spectrum.
  • Have the willingness to participate in the study and could read, communicate and cooperate with the completion of the consent form and questionnaire.
  • The age is 20 to 64 years old.
  • No need for any assistance in walking, and the gait is stable.
  • Appeared more than 2 times in the past month for more than 3 consecutive days without resolving or routine use of laxatives

Exclusion criteria

  • Diagnosis is organic brain disease, alcohol and substance abuse.
  • There have been problems with gastrointestinal bleeding or lesions.
  • Have a history of extensive abdominal surgery or gastrointestinal surgery.
  • There are medical considerations and medical expenses reduction activities.

Treatment and study plan

Baduanjin program

Other

The entire program continued for 6 months (December, 2018 to July, 2019), and the intervention was performed for 60 min 3 times per week; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program.

Primary outcomes

  1. Changes in Intestinal Peristalsis

    Time frame: 3 months and 6 months

    Change from Baseline bowel movement of four quadrants of abdomen at 3 months and 6 months

Secondary outcomes

  1. Changes in Constipation Assessment Scale

    Time frame: 3 months and 6 months

    Change from Baseline Constipation Assessment Scale at 3 months and 6 months. The nine symptoms evaluated included: bloating, increased gas delivery in the rectum, decreased / increase frequency of bowel movements, oozing water, rectal obstruction or pressure, bowel movements combined with rectal pain, low bowel movements, and inability to defecate. 3 points scoring method (0-2), 0 is no problem, 1 is a bit problem, 2 is a serious problem. The maximum total score is 18.

  2. Change in Patient Assessment of Constipation Symptoms

    Time frame: 3 months and 6 months

    Change from Baseline Patient Assessment of Constipation Symptoms at 3 months and 6 months. The 12 items are divided into 3 subscales: 4 items for abdominal symptoms, 3 items for rectal symptoms, and 5 items for fecal symptoms. Patient Assessment of Constipation Symptoms Scale items are rated on a 5-point scale ranging from 0 to 4 based on severity of each item. The maximum total score is 48.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

Exploring the Predictors of Constipation and the Effects of a Baduanjin Program on the Symptoms of Constipation in Adults With Chronic Schizophrenia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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