NCT03409393

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

January 4, 2018

Last Update Submit

September 13, 2018

Conditions

SchizophreniaSchizotypal DisorderFirst Episode PsychosisPsychotic DisordersSchizoaffective Disorder

Keywords

HumanDenmarkAdultAdolescentYoung AdultMaleFemalePhysical ActivityMaximum Oxygen ConsumptionResistance TrainingHigh-Intensity Functional TrainingAerobic ExerciseMotivationFeasibilityRelevanceHealth Behavior

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (11)

  • Assessment of changes in body weight

    Change from Baseline Body Weight at 2 months.

  • Assessment of changes in fat percentage

    Change from Baseline Fat Percentage at 2 months.

  • Assessment of changes in bone mass

    Change from Baseline Bone Mass at 2 months.

  • Assessment of changes in muscle mass

    Change from Baseline Muscle Mass at 2 months.

  • Assessment of changes in Visceral Fat

    Change from Baseline Visceral Fat at 2 months.

  • +6 more secondary outcomes

Other Outcomes (3)

  • Monitoring of training intensity (for the Intervention Group only)

    Through study completion, an average of 4 months

  • Adverse events

    Through study completion, an average of 4 months

  • Resource Consumption

    Through study completion, an average of 4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The COPUS intervention plus usual care (OPUS treatment).

Other: The COPUS interventionOther: Usual Care (OPUS treatment)

Control Group

OTHER

Usual care (OPUS treatment).

Other: Usual Care (OPUS treatment)

Interventions

The COPUS interventionOTHER

The COPUS intervention consists of 8 weeks of High-Intensity Functional Training (HIFT). The frequency of the training is 3 sessions per week and the duration is one hour per session. The intervention is group-based and supervised. Each training session includes warm-up (15 min), followed by 30 minutes of HIFT based on a range of varied functional exercises, including elements of strength training and aerobic exercise. The sessions are supervised by a trained physiotherapist and exercise physiologist supported by 2 two trained bachelor students in Sports Science.

Intervention Group
Usual Care (OPUS treatment)OTHER

Usual care include specialised early intervention treatment (OPUS treatment) and consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams include psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists. All team members, except for the psychiatrist, function as case managers. The ratio of patients to case managers must not exceed 12:1.

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Physical contraindications for physical activity
  • Pregnant (self-reported)
  • Unable to give adequately informed consent
  • Mentally disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OPUS

Brøndby, 2605, Denmark

Location

Related Publications (2)

  • Midtgaard J, Schnor H, Bjerre ED, Jespersen T, Jelsoe N, Frolund N, Seier S, Ronbog JW, Nordsborg NB, Ebdrup BH. Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial. Pilot Feasibility Stud. 2021 Aug 19;7(1):162. doi: 10.1186/s40814-021-00900-5.

    PMID: 34412705DERIVED

  • Larsen LQ, Schnor H, Tersbol BP, Ebdrup BH, Nordsborg NB, Midtgaard J. The impact of exercise training complementary to early intervention in patients with first-episode psychosis: a qualitative sub-study from a randomized controlled feasibility trial. BMC Psychiatry. 2019 Jun 21;19(1):192. doi: 10.1186/s12888-019-2179-3.

    PMID: 31226959DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaSchizotypal Personality DisorderPsychotic DisordersMotor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonality DisordersBehavior

Study Officials

  • Julie Midtgaard, Ph.D.

    The University Hospitals Centre for Health Research (UCSF) / Copenhagen University Hospital (Rigshospitalet)

    PRINCIPAL INVESTIGATOR

  • Helle Schnor, Ph.D.

    Mental health services in the Capital Region of Denmark, Psychiatric Center Glostrup

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The participants will be randomly assigned (1:1) to either an Intervention Group that in the initial study phase (week 0-8) receives the COPUS intervention plus usual care (i.e. OPUS treatment) or to a Control Group that only receives usual care in the initial phase. In the second phase of the study (week 8-16), participants allocated to the control group are offered the COPUS intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 24, 2018

Study Start

January 22, 2018

Primary Completion

June 20, 2018

Study Completion

August 1, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

DK(1)