Multimodal Physical Therapy Program in Schizophrenia

NCT02413164 | Completed DMC

• 1 other identifier: 12-2014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigators' study would evaluate the effectiveness of a multimodal exercise program on physical fitness, physical activity level and clinical symptomatology in patients with schizophrenia. DESIGN: Randomized controlled trial. SUBJECTS OF THE STUDY: People with schizophrenia who receiving treatment in Regional Hospital of Malaga. INTERVENTION: DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome.

Conditions

Schizophrenia

Keywords

Schizophrenia; Mental Health; Physical Therapy; Quality of life; Stigma; Positive and negative symptoms; Physical fitness; Physical activity

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  The Positive and Negative Syndrome Scale--Spanish adaptation. Peralta V. Psychometric properties of the positive and negative syndrome scale (PANSS) in schizophrenia. The spanish version of this scale has a (CCI=0.71 for possitive symptoms; CCI=0.80 for negative symptoms; CCI=0.56 In General psycopatology).

  Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)

Secondary Outcomes (8)

• International Physical activity Questionnaire. Short form (IPAQ-7)

  Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)

• Physical activity (accelerometry)

  Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)

• Self-efficacy and social support for physical activity (SS/SE)

  Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)

• 12-Item Short-Form Health Survey

  Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)

• Internalized Stigma of Mental Health questionnaire

  Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)

Study Arms (2)

Physical intervention group

EXPERIMENTAL

12 weeks of groupal sessions of individualised multimodal physiotherapy programme of therapeutic exercises with education healthy-style-of-life based, 2 times for week.

Other: A multimodal physiotherapy programme

Control group

NO INTERVENTION

This group will receive usual care and will be in wait list status for the duration of study, later the intervention will be offered to this group.

Interventions

A multimodal physiotherapy programme OTHER

Intervention: individualised Multimodal Physiotherapy Programme of therapeutic exercises with education healthy-style-of-life based. Groupal sessions two times per week during 12 weeks. Each session 60 minutes: 10 minutes of warm up, 20 minutes of strength and muscular endurance, 20 minuts of aerobic training, 10 minutes of cold-down. Intensity aerobic training: The training heart rate will be calculated according to recommendations of the American College of Sport Medicine (ACSM), it must oscillate between 55/65% and 90% of the HRmax. Initial four weeks: moderate intensity (55-69% HRmax); Following weeks according to each response, to higher level of training (70-89% HRmax). Strength training: individualised working with the principal muscular groups. 3 sessions using a weight which can repeat the exercise 10-15 times, increasing to a weight at which they can repeat the exercise 8-12 times.

Physical intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Persons with diagnosis of schizophrenia
• Have agreed to agreeing to participate in the study
• Have signed the informed consent
• Be able to complete scales and perform physical tests

You may not qualify if:

• Have a contraindication for performing physical intervention.
• Destabilization of the symptoms
• Be participating in a program of structured physical activity

Sponsors & Collaborators

• University of Malaga: lead
• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: collaborator

Study Sites (1)

IBIMA

Málaga, Málaga, 29009, Spain

Location

Related Publications (1)

• Perez-Cruzado D, Cuesta-Vargas AI, Vera-Garcia E, Mayoral-Cleries F. The relationship between quality of life and physical fitness in people with severe mental illness. Health Qual Life Outcomes. 2018 May 2;16(1):82. doi: 10.1186/s12955-018-0909-8.

  PMID: 29720196 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychological Well-Being; Social Stigma; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personal Satisfaction; Behavior; Social Behavior

Study Officials

• Antonio I Cuesta Vargas, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 9, 2015
• Study Start: March 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: May 1, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-01

Locations

ES (1)