Effects of Acute Physical Activity in Patients With Exhaustion Disorder

NCT06429423 | Completed

• 1 other identifier: 2022-04943-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exhaustion; Syndrome

Keywords

burnout; fatigue; psychological stress; physical activity; acute exercise; mood; heart rate variability

Outcome Measures

Primary Outcomes (3)

• Fatigue

  Fatigue is defined as "a persistent sense of physical, emotional, and/or cognitive tiredness or exhaustion". Feelings of energy and fatigue is measured with the vigor and fatigue subscales of Profile of Mood States (POMS). It assesses short-term mood states and respondents are instructed to rate how the feel "right now". The total score ranges from 0 to 28 and a higher score means a worse outcome. It is a valid and reliable measure of intensities of fatigue and energy mood states and is recommended to be used in experimental settings to measure short-term intensity of energy and fatigue moods.

  Fatigue is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bout.

• Energy/vigor

  The adopted definition of energy is "an individual's potential to perform mental and physical activity". Feelings of energy and fatigue is measured with the vigor and fatigue subscales of Profile of Mood States (POMS). It assesses short-term mood states and respondents are instructed to rate how the feel "right now". The total score ranges from 0 to 32 and a higher score means a better outcome. It is a valid and reliable measure of intensities of fatigue and energy mood states and is recommended to be used in experimental settings to measure short-term intensity of energy and fatigue moods.

  Energy/vigor is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bout

• State anxiety

  State anxiety will be measured using the 20-item state subscale of The State-Trait Anxiety Inventory (STAI-Y1). Respondents rate how they feel "right now" on a 4-point Likert Scale (e.g., "I am tense"). A global score of the transient condition of state anxiety is calculated, ranging from 20 to 80. Higher scores correlates with greater anxiety. It is extensively used in previous studies of acute exercise and there is support for the STAI-Y1 being sensitive to change in response to acute aerobic exercise.

  State anxiety is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bou

Secondary Outcomes (5)

• Stress.

  Stress is measured in both conditions at the following time-points: immediately before the exercise bout, immediately after the exercise bout, 30 minutes after the exercise bout, 6 hours after the exercise bout, and 24 hours after the exercise bout.

• Perceived psychological discomfort.

  SUD is measured in both conditions at the following time-points: immediately before the exercise bout; during the exercise at 3 time points: 5 min into the exercise, 10 min into the exercise, and 15 min into the exercise

• Perceived Exertion.

  RPE is measured in both conditions at the following time-points: immediately before the exercise bout; during the exercise at 3 time points: 5 min into the exercise, 10 min into the exercise, and 15 min into the exercise

• Salivary cortisol

  Cortisol is measured in both conditions at the following time points: 10 minutes before each exercise bout; 5 minutes after each exercise bout; and 35 minutes after each exercise bout.

• Heart rate variablity (HRV)

  HRV is measured in both conditions at the following time points: 5 minutes before exercise bout; ca 8 minutes after exercise bout; and ca 38 minutes after exercise bout.

Study Arms (2)

Exhaustion disorder (ED)

EXPERIMENTAL

Patients with diagnosed exhaustion disorder (F43.8A in Swedish ICD-10).

Behavioral: Acute exercise low intensity; Behavioral: Acute exercise moderate intensity

Control group

ACTIVE COMPARATOR

Age- and sex-matched healthy control participants.

Behavioral: Acute exercise low intensity; Behavioral: Acute exercise moderate intensity

Interventions

Acute exercise low intensity BEHAVIORAL

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.

Control group; Exhaustion disorder (ED)

Acute exercise moderate intensity BEHAVIORAL

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.

Control group; Exhaustion disorder (ED)

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For ED-patients:
• Confirmed primary diagnosis ED by a physician
• Assessed to not be in the acute phase of ED
• considered by a physician and/or a psychologist as suitable for participating in a study including performing physical activity
• Age of 35-55 years
• For control group:
• Self-reported good health (no known somatic or psychiatric disease)
• Age of 35-55 years

You may not qualify if:

• Chronic fatigue syndrome (CFS)
• Post-covid
• Dementia
• Bipolar and/or psychotic disorder
• Current substance abuse
• Fibromyalgia
• Elevated suicide risk
• Medication with beta-blockers
• chronic obstructive lung disease
• hypertension/dyslipidemia
• cardiovascular disease
• If participant has ongoing infection (such as a cold) on testday, testing is delayed until she/he is recovered.

Sponsors & Collaborators

• Victoria Blom: lead
• Avonova Health AB: collaborator
• Jenny Kling, Doctoral student, licensed psychologist, The Swedish School of Sport and Health Sciences: collaborator

Study Sites (1)

Victoria Blom

Stockholm, 11433, Sweden

Location

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MeSH Terms

Conditions

Syndrome; Burnout, Psychological; Fatigue; Stress, Psychological; Motor Activity

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Signs and Symptoms

Study Officials

• Victoria Blom, Ass. prof.

  The Swedish School of Sport and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor in psychology, head of department Institution for physical activity and health, licensed psychologist

Model Details: The design is a two-armed intervention with two groups (30+30), one which is patients with ED, and the other an age- and sex matched control group with overall healthy individuals. The two trial conditions will be performed in a counter-balanced randomized order on two separate days with at least one week apart. Participants will be randomized regarding order of two different intensities of physical activity bouts. The participants will perform the two conditions of physical activity bouts at approximately the same time in the morning/forenoon with at least 1 week in between conditions.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: May 28, 2024
• Study Start: February 21, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)