Clinical Trials Directory

Trials / Completed

CompletedNCT03542396

Evaluation of a Group Therapeutic Exercise Program

ImPuls - a Group Therapeutic Exercise Intervention for the Outpatient Psychotherapeutic Context

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
University Hospital Tuebingen · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Moderate to vigorous physical activity can reduce symptoms of mental disorders like major depression, anxiety disorders, insomnia, and ADHD. However, in Germany there are no group therapeutical exercise programs for psychotherapy patients in an outpatient context. The current study aims to examine the effectiveness of a manualized exercise program, named ImPuls, which consists of a supervised and non-supervised endurance training in moderate to vigorous intensity and behaviour change techniques.

Detailed description

The current study aims to examine the efficacy (i.e., symptom reduction, increase of heart rate variability, improvement of sleep quality, increase of intrinsic motivation to engage in physical activity, increase of the level of physical activity) of a three-months manualized group exercise program, named ImPuls. The program contains supervised and non-supervised endurance training combined with behaviour change techniques. The manual was designed for patients with major depression, anxiety disorders, insomnia, and ADHD who are waiting for psychotherapeutic treatment. It is assumed that the program will improve the psychopathological symptoms of the different mental disorders. Heart rate variability, level of exercise, sleep quality, motivation and symptoms are measured by objective measures (physiological measurements, accelerometers) and subjective measures (structured interviews and questionnaires). In a randomized controlled trial, ImPuls will be evaluated (n = 38 intervention group vs. n = 37 control group). For four weeks, small group sessions of three to four people take place three times a week, combining endurance exercise (i.e., running) and behaviour change techniques, supervised by two therapists. The training is based on the actual evidence for effective therapeutic effects on psychopathological symptoms, individually adapted to each patient's fitness level (60-80% of the maximal heart rate) and lasts 30 minutes. In the following eight weeks, participants are encouraged to engage in physical activity independently for two to three times a week. It is assumed that the program will reduce symptoms of the different mental disorders as well as increase the heart rate variability, improve sleep quality, intrinsic motivation to engage in physical activity, and the engagement in physical activity. Safety will be monitored throughout the study.

Conditions

Interventions

TypeNameDescription
BEHAVIORALImPulsParticipants receive an supervised exercise intervention and behaviour change techniques for 4 weeks and, after that, they are encouraged to engage in physical activity for 8 weeks independently. During this 8-week individual phase, patients have weekly phone contacts with a psychotherapist

Timeline

Start date
2018-03-01
Primary completion
2020-11-09
Completion
2020-11-09
First posted
2018-05-31
Last updated
2020-11-20

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03542396. Inclusion in this directory is not an endorsement.