Aerobic Group Exercise for Adolescents With Depression

NCT04695145 | Completed

• 1 other identifier: 2020-03364
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adolescent; depression; exercise intervention; biomarker; cost evaluation; qualitative

Outcome Measures

Primary Outcomes (1)

• Change in Children's Depression Rating Scale- Revised (CDRS-R)

  Clinician administered interview about symptoms of depression, range 17 (best) - 113 (worst)

  After intervention (at 13 weeks) and at follow-up (at 52 weeks)

Secondary Outcomes (7)

• Change in Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-A17-SR)

  Every two weeks during the 12 week intervention and monthly during the preceding year.

• Change in Children Global Assessment Scale (C-GAS),

  After intervention (at 13 weeks) and at follow-up (at 52 weeks)

• Change in Outcome Rating Scale (ORS)

  Every two weeks during the 12 week intervention and monthly during the preceding year.

• Change in Aerobic capacity

  After intervention (at 13 weeks) and at follow-up (at 52 weeks)

• Change in Muscular strength

  After intervention (at 13 weeks) and at follow-up (at 52 weeks)

Study Arms (2)

Aerobic exercise in group

EXPERIMENTAL

The patients will participate in aerobic group exercise for 60 minutes three times a week for 12 weeks with continuous heart rate monitoring. The sessions will be held in a small gym under supervision of a personal trainer with special training in medical issues. The exercise will be monitored with continuous heart rate registration. The group training session will begin with a warm-up to increase heart rate including balance tasks and dynamic stretching for 10-15 minutes. Every third session will be pure aerobic training, every third session will be strengthening exercises designed to also increase heart rate, and every third session will be a mixed session of both aerobic and strength exercises. All major muscle groups will be used at each session. Interval training with gradually increased intensity throughout the program will be applied.

Behavioral: Aerobic exercise in group

Group sessions with leisure activities

ACTIVE COMPARATOR

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.

Behavioral: Group sessions with leisure activities

Interventions

Aerobic exercise in group BEHAVIORAL

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

Aerobic exercise in group

Group sessions with leisure activities BEHAVIORAL

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.

Group sessions with leisure activities

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• DSM-5 mild to moderate depression
• Who have received evaluation and basic psychosocial interventions for 4-8 weeks (minimum four visits) without response, i.e. not achieved improvement by at least 50 % as assessed from clinical records

You may not qualify if:

• Eating disorder
• High risk for suicide
• Intellectual disability
• Actual physical activity the last four weeks meeting the level for sustained health by American College of Sports Medicine, i.e. at least 150 min per week of moderate intensity or 75 min per week of high intensity38
• Adjustment of antidepressant medication within the last four weeks or stimulants the last two weeks
• Chronic somatic illness precluding exercise
• In need of interpreter
• Social circumstances interfering with a regular exercise schedule
• Concomitant psychotherapy

Sponsors & Collaborators

• Lund University Hospital: lead
• Region Halland: collaborator
• Halmstad University: collaborator
• The Rydberg Laboratory for Applied Sciences, Halmstad, Sweden: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Child and Adolescent Psychiatry

Halmstad, 30290, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Exercise; Population Groups

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Demography; Population Characteristics

Study Officials

• Håkan Jarbin, MD, PhD

  University Hospital of Lund, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The baseline and outcome assessor is not working at the clinic and is not informed of treatment mode. The patient is informed at the beginning of the interview not to disclose any information about mode of treatment. All interviews are recorded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Study - pilot version

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 5, 2021
• Study Start: March 8, 2021
• Primary Completion: June 18, 2021
• Study Completion: March 15, 2022
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)