CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Acute exercise low intensity +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT06429423
NCT06429423N/ACompleted

Acute Psychological and Physiological Exercise Effects Among Patients With Stress-related Exhaustion Disorder. Role of Exercise Intensity.

Victoria Blom·interventional·Posted May 28, 2024·Updated May 31, 2024

In Brief

A clinical study evaluating Acute exercise low intensity and Acute exercise moderate intensity for Exhaustion; Syndrome. Completed, enrolled 60 participants across 1 site.

Detailed Summary

A new stress-related diagnosis, Exhaustion disorder (ED), was introduced in the Swedish version of ICD-10 in 2005 and has since then increased rapidly. The condition is long-lasting and debilitating, characterized by considerable and persistent fatigue, insomnia, and impaired cognitive function. The diagnosis is still relatively unexplored and there is no consistent knowledge of, among other things, which interventions that work. Research indicates that physical activity can have positive effects on depression, anxiety, and stress. However, there is little knowledge today about the relationship between the dose of physical activity and stress-related illness. It is also not clear how physical activity can be used in the treatment of stress-related illness. The purpose of this project is to gain increased knowledge about the immediate physiological and psychological effects of physical activity for people with diagnosed ED. The project will investigate the psychological and physiological effects of two different intensities of physical activity in people with ED compared to healthy controls. The information from the study also aims to provide a basis for a second part of the project where treatment including physical activity is carried out with people with ED, in a randomized controlled design.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden

Timeline

N/ACompletedFinished
202420252026
First PostedMay 28, 2024
Enrollment StartFeb 21, 2023
Primary CompletionJan 4, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.1 years ago

Interventions

Acute exercise low intensitybehavioral

A 15-minute exercise on low intensity on a cycle ergometer. Immediately before, immediately after and 30 minutes after exercise participants will fill out questionnaires regarding feelings of fatigue, energy, anxiety and stress and measure saliva cortisol. Three times during the exercise, they will rate level of exertion (RPE) and feelings of distress on a VAS-scale. During the 24 hours following the exercise bout they will wear a heart rate strap and an accelerometer measuring heart rate variability and activity level. Twice during that time, once in the evening, and once in the morning after, participants will answer questionnaires regarding mood state.

Acute exercise moderate intensitybehavioral

A 15-minute exercise on moderate intensity on a cycle ergometer. Immediately before, immediately after and 30 minutes after exercise participants will fill out questionnaires regarding feelings of fatigue, energy, anxiety and stress and measure saliva cortisol. Three times during the exercise, they will rate level of exertion (RPE) and feelings of distress on a VAS-scale. During the 24 hours following the exercise bout they will wear a heart rate strap and an accelerometer measuring heart rate variability and activity level. Twice during that time, once in the evening, and once in the morning after, participants will answer questionnaires regarding mood state.