Schizophrenia Clinical Trial
— COPUSOfficial title:
Feasibility and Relevance of High-Intensity Functional Training in Patients Undergoing Specialised Early Intervention Treatment for First-Episode Psychosis
Verified date | September 2018 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the COPUS study is to investigate, whether it is possible to recruit and retain young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional Training intervention (HIFT) (i.e. COPUS Intervention) and to investigate if oxygen uptake, body composition and physical function improves following participation in the intervention.
Status | Completed |
Enrollment | 27 |
Est. completion date | August 1, 2018 |
Est. primary completion date | June 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Age between 18 and 35 years - Diagnosed with Schizophrenia or Schizotypal disorders - Undergoing OPUS treatment for at least 6 months or stabilized medical anti-psychotic treatment - Danish speaking Exclusion Criteria: - Physical contraindications for physical activity - Pregnant (self-reported) - Unable to give adequately informed consent - Mentally disabled |
Country | Name | City | State |
---|---|---|---|
Denmark | OPUS | Brøndby |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Mental Health Services in the Capital Region, Denmark, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Monitoring of training intensity (for the Intervention Group only) | Determination of whether the training intensity is adequate to increase Physical Fitness, the workload during training is continuously measured. A validated device called Actiheart which is both an accelerometer and a heart rate monitor is used to measure workload. | Through study completion, an average of 4 months | |
Other | Adverse events | We will continuously record adverse events that may arise as a result of the intervention, including physical damage, discomfort and any deterioration of symptoms. The adverse events will be registred both in the intervention period and in the Control Group training period. | Through study completion, an average of 4 months | |
Other | Resource Consumption | In order to evaluate the sustainability of the intervention, we want to register how much time (in minutes) OPUS staff spends on the project | Through study completion, an average of 4 months | |
Primary | Assessment of changes in Physical Fitness (VO2max) | Assessed by the maximum amount of oxygen the body can utilize during a specified period of intense exercise. | Change from Baseline Physical Fitness (VO2max) at 2 months. | |
Primary | Recruitment Rate | Registration of patients enrolled in the study compared to the total number of eligible patients. | Registration of recruitment occurs in the 4 weeks prior to the baseline tests. | |
Primary | Retention Rate | Registration of the participants attendance in the High-Intensity Functional Training compared with the number of possible training sessions during the period. | From baseline up to 4 months. | |
Secondary | Assessment of changes in body weight | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining body weight. | Change from Baseline Body Weight at 2 months. | |
Secondary | Assessment of changes in fat percentage | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining fat percentage. | Change from Baseline Fat Percentage at 2 months. | |
Secondary | Assessment of changes in bone mass | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining bone mass. | Change from Baseline Bone Mass at 2 months. | |
Secondary | Assessment of changes in muscle mass | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining muscle mass. | Change from Baseline Muscle Mass at 2 months. | |
Secondary | Assessment of changes in Visceral Fat | The participants are placed on a bioelectric impedance scale which is a non-invasive valid measurement method for determining visceral fat. | Change from Baseline Visceral Fat at 2 months. | |
Secondary | Assessment of changes in Resting Blood Pressure | The participants' Resting Blood Pressure are tested according to the American Heart Association practice guidelines for blood pressure Measurement. | Change form Baseline Resting Blood Pressure at 2 months. | |
Secondary | Assessment of changes in countermovement jump height | Determination of potential changes in countermovement jump height measured using the non-invasive Optojump system (www.optojump.com) | Change form Baseline Jump Height at 2 months. | |
Secondary | Assessment of changes in Leg Muscle Strength | Determination of potential changes in leg muscle strength by the non-invasive 30-Second Chair Stand test. The test measures how many times the participant can reach a full standing position from a sitting position in 30 seconds. Score range from 0 and up with a higher score being considered as a better outcome. | Change form Baseline Leg Muscle Strength at 2 months. | |
Secondary | Assessment of changes in Hand Grip Strength | Determination of potential changes in grip strength measured quantitatively using a hand dynamometer. | Change form Baseline Hand Grip Strength at 2 months. | |
Secondary | Assessment of changes in Balance | Determination of potential changes in balance using the Flamingo Balance Test. The participant stands on a 3 centimeter wide beam while holding the instructors hand. The tests then measures how many times the participant loses balance in 60 seconds.Score range from 0 and up with a lower score being considered as a better outcome. | Change form Baseline balance at 2 months. | |
Secondary | Assessment of changes in Self-reported Physical Activity Behavior | Assesment of changes in self-reported physical activity behaviour using the Physical Activity Scale (PAS). The PAS measures self-reported amount of time spent on different physical activities, such as sports, work, and leisure time during 24 hours on an average weekday. The activities are organized in nine different metabolic equivalent (MET) levels ranging from sleep/rest (0.9 METs) to high-intensity physical activities (>6 METs). MET is the Metabolic Equivalent of Task and is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate. Therefore, higher MET scores in the Physical Activity Scale indicates a better outcome than lower scores. | Change from Baseline Physical Activity Behaviour at 2 months. |
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