Exercise in Severe Mental Illness. The PsychiActive Project
Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this randomized controlled trial is to study the effects of exercise on body weight, body composition, anthropometric and fasting blood measures, physical fitness, pulmonary function, quality of life, and lifestyle habits in patients with severe mental illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2015
CompletedFirst Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedSeptember 5, 2018
September 1, 2018
5 months
November 10, 2017
September 3, 2018
Conditions
Outcome Measures
Primary Outcomes (8)
Body weight
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
12 weeks
Fat mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
12 weeks
Lean mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
12 weeks
Waist girth
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed at the midpoint between the last rib and the iliac crest
12 weeks
Hip girth
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
12 weeks
Blood glucose
In milligram per deciliter. Collected in the morning after an overnight fast
12 weeks
Blood cholesterol
In milligram per deciliter. Collected in the morning after an overnight fast
12 weeks
Blood triglyceride
In milligram per deciliter. Collected in the morning after an overnight fast
12 weeks
Secondary Outcomes (16)
Lower body strength
12 weeks
Upper body strength
12 weeks
Aerobic endurance
12 weeks
Lower body flexibility
12 weeks
Upper body flexibility
12 weeks
- +11 more secondary outcomes
Study Arms (2)
Exercise
EXPERIMENTALExercise training for 12 weeks (aerobic and resistance training trice a week).
Usual treatment
NO INTERVENTIONUsual treatment during 12 weeks, coinciding with exercise intervention time frame.
Interventions
Exercise training for 12 weeks (aerobic and resistance training trice a week)
Eligibility Criteria
You may qualify if:
- Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.
You may not qualify if:
- Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Pablo de Olavide
Seville, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 24, 2017
Study Start
March 16, 2015
Primary Completion
August 5, 2015
Study Completion
December 23, 2015
Last Updated
September 5, 2018
Record last verified: 2018-09