Aerobic Group Exercise for Adolescents With Depression

NCT04695145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-05-23

No results posted yet for this study

Summary

The aim is to evaluate aerobic group exercise versus leisure group activities in adolescents with mild to moderate depression.

Primary outcome is Children's Depression Rating Scale - Revised (CDRS-R). Secondary outcomes are Clinical Global Impressions - Severity and Improvement scales (CGI), self-reported Quick Inventory of Depression Symptomatology (QIDS- A17-SR), the self-reported Outcome Rating Scale (ORS), clinician rated Children Global Assessment Scale (C-GAS), aerobic capacity (VO2max), muscular strength, body, Body Mass Index (BMI), presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples and a cost evaluation rated by parents with Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (Tic-P). Further objectives are qualitative interviews to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced and a validation of QIDS- A17-C and QIDS- A17-SR versus CDRS-R will be performed.

Conditions

  • Depressive Disorder, Major

Interventions

BEHAVIORAL

Aerobic exercise in group

Progression The goal with every new week should be making every workout a little bit harder than the week before. Strength sessions * Week 1-6: 12-18 reps x 2 set per exercise and muscle 30 s rest between exercises * Week 7-12: 10-12 reps x 3 set per exercise and muscle 20 s rest between exercises Adding weight with gym equipment or changing body position in the exercises to succeed with the rep scheme and making it harder as the group develop their physical and mental ability. Conditioning sessions * Week 1-6: 75 seconds work time x 1 set per exercise 30 seconds of rest between exercises * Week 7-12: 50 seconds work time x 2 set per exercise 20 seconds of rest between exercises Mixed sessions * Week 1-6: 35 s work time per exercise 25 s rest between exercises x 2 rounds * Week 7-12: 45 s work time per exercise 15 s rest between exercises x 2 rounds

BEHAVIORAL

Group sessions with leisure activities

The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or watching movies together.

Sponsors & Collaborators

  • Region Halland

    collaborator OTHER
  • Halmstad University

    collaborator OTHER
  • The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden

    collaborator UNKNOWN
  • Karolinska University Hospital

    collaborator OTHER
  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Håkan Jarbin, MD, PhD · University Hospital of Lund, Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-06-18
Completion
2022-03-15

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695145 on ClinicalTrials.gov