Exercise Enhances: A randomized controlled trial on aerobic exercise as depression treatment augmentation strategy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24898

Enrollment

120

Registered

2020-03-06

Start date

2020-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

The intervention condition receives CAU combined with physical exercise according to prescription: 12 weeks with one supervised and two at-home moderate-intensity sessions. The supervised weekly exerc

Eligibility

Inclusion criteria

Inclusion criteria: • Adult: Age 16+ • Current depressive episode

Exclusion criteria

Exclusion criteria: • Impossibility to obtain a valid informed consent • Physical, cognitive, or intellectual impairments interfering with participation • High health risks of physical activity (assessed using the Physical Activity Readiness Questionnaire; Shephard et al, 1981) • Lifetime manic episode • Current psychosis • Insufficient comprehension of the Dutch language

Design outcomes

Primary

Measure	Time frame
Depressive symptoms: Inventory of Depressive Symptomatology-Self Report (IDS-SR), assessed at each time point.	—

Secondary

Measure	Time frame
Depressive remission (T4-T8): Structured Clinical Interview for DSM-5 (SCID-5-S) Fitness: - Self-rated physical activity level: The International Physical Activity Questionnaire (IPAQ; Vandelanotte, et al., 2005), assessed at each time point - Objective physical activity level and heart rate: A non-invasive activity-tracker (‘FitBit’) will be used in the adjunct exercise intervention arm to track exercise frequency, duration and intensity from three days before T0 (or as soon after informed consent) till T5. The FitBit is an important feature of the intervention, as it allows self-dosing during the at-home exercise sessions, and helps patients motivate themselves hence contributing to adherence - Objective fitness: Fitness tests at T0 and T4 in 15 % of the patients (randomly selected). The main endpoint is improvement in cardiorespiratory fitness. The tests will be performed by a trained psychomotor therapist with a physician nearby and on call. An electrocardiogram and blood pressure will be assessed before each test and during testing at the end of every minute, at peak, and immediately post exercise; after minute 2 of active recovery; and at 1, 3, 5, and during seated recovery. Values will be calculated based on body weight as ml/kg/min and categorized according to standardized values for men and women in different age categories. Mood: Patients will fill out a positive and negative mood rating (Visual Analogue Scales) directly before and after each supervised exercise session.They are stimulated to also use the mood ratings at home to monitor direct mood benefits. This is a technique to self-empower patients to motivate themselves and hence contributes to adherence and long-term exercise use. This is already part of usual psychomotor therapy care. At-home exercise: At the end of each supervised exercise session, patients fill out a brief questionnaire on the type, frequency, duration and intensity (mean and peak heart rate, as measured by the FitBit) of the	—

Measure

Time frame

Depressive remission (T4-T8): Structured Clinical Interview for DSM-5 (SCID-5-S) Fitness: - Self-rated physical activity level: The International Physical Activity Questionnaire (IPAQ; Vandelanotte, et al., 2005), assessed at each time point - Objective physical activity level and heart rate: A non-invasive activity-tracker (‘FitBit’) will be used in the adjunct exercise intervention arm to track exercise frequency, duration and intensity from three days before T0 (or as soon after informed consent) till T5. The FitBit is an important feature of the intervention, as it allows self-dosing during the at-home exercise sessions, and helps patients motivate themselves hence contributing to adherence - Objective fitness: Fitness tests at T0 and T4 in 15 % of the patients (randomly selected). The main endpoint is improvement in cardiorespiratory fitness. The tests will be performed by a trained psychomotor therapist with a physician nearby and on call. An electrocardiogram and blood pressure will be assessed before each test and during testing at the end of every minute, at peak, and immediately post exercise; after minute 2 of active recovery; and at 1, 3, 5, and during seated recovery. Values will be calculated based on body weight as ml/kg/min and categorized according to standardized values for men and women in different age categories. Mood: Patients will fill out a positive and negative mood rating (Visual Analogue Scales) directly before and after each supervised exercise session.They are stimulated to also use the mood ratings at home to monitor direct mood benefits. This is a technique to self-empower patients to motivate themselves and hence contributes to adherence and long-term exercise use. This is already part of usual psychomotor therapy care. At-home exercise: At the end of each supervised exercise session, patients fill out a brief questionnaire on the type, frequency, duration and intensity (mean and peak heart rate, as measured by the FitBit) of the

—

Contacts

Public ContactMichele Schmitter

Pro Persona

m.schmitter@propersona.nl0031243837811

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)