DepressionLIFENCT06387732
Mechanisms Underlying Antidepressant Effects of Physical Activity
A study testing Aerobic exercise and Stretching and relaxation in people with Depression, run by University College, London at 1 site in United Kingdom.
Trial summary
It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Aerobic exercise and Stretching and relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PHQ9≥12 (moderate depression).
- Current physical activity level below 30 min moderate physical activity, once per week.
- Fluency in English.
- Willingness to undergo the interventions.
- Age 18-60.
- Willing and able to provide written informed consent.
Who cannot join
- Medical contraindications to either intervention.
- Neurological illness.
- Past or current diagnosis of psychosis, bipolar disorder, or substance/alcohol use disorder, unless restricted to a depressive episode.
- Unable to complete self-administered cognitive or questionnaire assessments.
- Symptoms or cognitive impairment that would limit capacity to consent.
- Pregnancy.
- Regular use of anti-inflammatory medication (more than once per week).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Cognitive Neuroscience, University College London
London, WC1N 3AZ
Jonathan P Roiser, PhD, +44 7779 589303, j.roiser@ucl.ac.uk
Emily J Hird, PhD, 07514570402, e.hird@ucl.ac.uk
About this study
Official title: The Mechanisms Underlying the Antidepressant Effects of Physical Activity
It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions.
To date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation.
The key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements.
Read the detailed description
The primary objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining effects on a range of potential clinical and mechanistic factors: depressive symptoms; immune-metabolic function; activation in the brain's reward and effort processing circuitry using functional magnetic resonance imaging (fMRI); cognitive tasks, focusing on reward processing; and a subset (approximately one-third) of participants will complete L-6-[18F] fluoro-3,4-dihydroxyphenylalnine (18F-DOPA) positron emission tomography (PET).
The secondary objectives are to assess: (1) the degree to which changes in the mechanistic factors are related to changes in interest-activity symptoms of depression resulting from aerobic exercise; (2) whether baseline mechanistic or clinical factors are associated with symptomatic improvement measured by symptom questionnaires following the exercise intervention; (3) whether aerobic exercise-induced changes in the brain circuits underlying cognitive control overlap with those implicated in motivation.
The trial will use an RCT design, with depressed participants randomised to eight weeks of either 45 minutes aerobic exercise of moderate-to-vigorous intensity activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125). The target sample size following expected attrition is N~105 per arm. Participants will complete the trial in staggered cohorts, with no more than six participants per class.
Blood and saliva samples will be taken before the intervention at baseline (between weeks -1 and 0), mid-intervention (week 3 and week 4), and post-intervention (week 9 to week 14) visits, to assess changes in immune-metabolic markers. Blood and saliva samples will also be collected at baseline and post-intervention from approximately 30 healthy controls.
Functional neuroimaging during effort-based decision-making and cognitive control will be taken at baseline and post-intervention. The same functional neuroimaging measures will also be collected at baseline and post-intervention from approximately 30 healthy controls.
Cognitive assessments will be completed online at baseline, every other week during the intervention (week 1, week 3, week 5, week 7), and post-intervention. The same cognitive assessments will also be collected at identical time-windows from approximately 30 healthy controls.
Questionnaire assessments will be completed online at baseline, every other week (week 2, week 4, week 6) and post-intervention (week 9 to 14). The same questionnaire assessments will be collected at baseline and post-intervention from approximately 30 healthy controls.
Accelerometers will measure physical activity continuously at baseline and during the intervention. Fitness testing will provide a measure of cardiovascular fitness at baseline and post-intervention visits. Daily depressive symptoms will be recorded using abbreviated scales using the Neureka smartphone app throughout the intervention. Three-monthly follow up of symptoms/cognition from baseline over six months will assess the durability of effects (week 21 and week 33).
In a subset of participants, approximately one-third of the participants will also complete a positron emission tomography (PET) scan pre-randomisation and at a visit during weeks 4-9 to 14, to assess dopamine synthesis capacity. The same PET scan will also be collected from approximately 30 healthy controls.
- Conditions
- Depression
- Being tested
- Aerobic exercise, Stretching and relaxation
- Keywords
- Aerobic exercise, Effort, Decision-making, Cognitive control, Dopamine, Inflammation, Motivation
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
This will be delivered by coaches in a small group class format. Participants will complete the trial in staggered cohorts, with no more than six participants per class. Intervention activities will be tailored to each individual's own ability and fitness level.
Stretching and relaxationOther
This will be delivered by coaches in a small group class format. Participants will complete the trial in staggered cohorts, with no more than six participants per class. Intervention activities will be tailored to each individual's own ability and fitness level.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Participants will be randomised to eight weeks of 45 min aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125). Receives: Other: Aerobic exercise |
| Stretching and relaxation | Active comparator | Participants will be randomised to eight weeks of 45 min aerobic exercise of stretching and relaxation (control group: three times per week, N=125). Receives: Other: Stretching and relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 score
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). Minimum score is 0, maximum score is 27. Higher scores mean a worse outcome.
Measured: Post-intervention (week 9 to week 14)
Secondary outcomes (22)
Physical activity
Physical activity will be measured continuously by accelerometers and between baseline, post-intervention and follow-up (weeks 21 and 33) using the International Physical Activity Questionnaire (IPAQ). The minimum score is 0, and there is no maximum score. A higher score means more physical activity.
Measured: Baseline assessment period (between weeks -1 and 0) to post-intervention (week 9 to week 14), and follow-up (weeks 21 and 33)
Aerobic capacity: CPET
Aerobic capacity will be measured by the Cardiopulmonary Exercise Test (CPET), which is a physical fitness test.
Measured: Baseline (between weeks -1 and 0) and post-intervention (week 9 to week 14)
Ecological Momentary Assessment
Brief daily depressive symptoms will be recorded throughout the intervention, using abbreviated scales, through the Neureka smartphone app. Minimum score per item is -3, maximum score per item is 3. Higher scores mean a worse outcome.
Measured: Baseline assessment period (between weeks -1 and 0) to post-intervention (week 9 to week 14)
Inflammatory response (cytokines)
Inflammatory cytokines (pg/mL) will assess changes in inflammatory responses.
Measured: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Inflammatory response (genetic markers)
Transcriptional markers (fold change) will assess changes in inflammatory responses.
Measured: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Inflammatory response (flow cytometry immunophenotype)
Flow cytometry immunophenotype (% cells) will assess changes in inflammatory responses.
Measured: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Neuroendocrine system
Cortisol over the day (pg/mL) will assess changes in the neuroendocrine system.
Measured: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Metabolic function
Metabolic blood markers (mg/dl) will assess changes in metabolic function.
Measured: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Dopamine synthesis capacity
In a subset of participants, dopamine synthesis capacity measured by 18F-DOPA PET will be taken.
Measured: Baseline (between weeks -1 and 0) and post-intervention (week 4-9 to week 14)
Functional magnetic resonance imaging (fMRI) during cognitive tasks
Participants will complete effort-based decision making and cognitive control tasks during fMRI.
Measured: Baseline (between weeks -1 and 0) and post-intervention (week 9 to week 14)
Online cognitive tasks
Participants will complete online cognitive tests of effort-based decision-making and cognitive control, alongside other tests of reward processing.
Measured: During every other week of the intervention (weeks -1/0, week 1, week 3, week 5, week 7, week 9 to week 14)
Depression symptoms
Depression symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9). Minimum score is 0, maximum score is 27. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6)
Anxiety (GAD7 score)
Anxiety will be measured by the Generalised Anxiety Disorder Assessment (GAD7). Minimum score is 0, maximum score is 21. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Anxiety (STAI score)
Anxiety will be measured by the State-Trait Anxiety Inventory (STAI). Minimum score is 20, maximum score is 80. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Anhedonia (SHAPS score)
Anhedonia will be measured by the Snaith-Hamilton Pleasure Scale (SHAPS). Minimum score is 14, maximum score is 56. Higher scores mean a better outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Anhedonia (DARS score)
Anhedonia will be measured by the Dimensional Anhedonia Rating Scale (DARS). Minimum score is 0, maximum score is 68. Higher scores mean a better outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Apathy
Apathy will be measured by the Apathy Evaluation Scale (AES). Minimum score is 18, maximum score is 72. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Fatigue
Fatigue will be measured by the Fatigue Severity Scale (FSS). Minimum score is 9, maximum score is 63. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Cognitive impairment
Cognitive impairment will be measured by the British Columbia Cognitive Complaints Inventory (BC-CCI). Minimum score is 0, maximum score is 18. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Self-efficacy
Self-efficacy will be measured by the General Self-Efficacy Scale (GSES). Minimum score is 8, maximum score is 40. Higher scores mean a better outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Self-esteem
Self-esteem will be measured by the Single-Item Self-Esteem Scale (SISES). Minimum score is 1, maximum score is 7. Higher scores mean a better outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0, maximum score is 21. Higher scores mean a worse outcome.
Measured: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Apr 2024
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will use a single-site parallel group design with depressed participants randomised to eight weeks of either 45 minutes of aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Queen Mary University of London, University of Dublin, Trinity College
- Responsible party
- Sponsor
- Investigators
- Jonathan P Roiser, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387732
- Sponsor's protocol ID
- 161223
- Acronym
- LIFE
- Status last verified
- Sep 2025
- First submitted
- 15 Dec 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified questionnaire, cognitive, activity, EMA and immune-metabolic data through online repositories. We will share de-identified MRI and PET data on request through managed access agreements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanisms Underlying the Antidepressant Effects of Physical Activity
- ClinicalTrials.gov ID
- NCT06387732
- Acronym / sponsor ID
- LIFE / 161223
- Conditions
- Depression
- Keywords
- Aerobic exercise, Effort, Decision-making, Cognitive control, Dopamine, Inflammation, Motivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- King's College London, Queen Mary University of London, University of Dublin, Trinity College
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions.
To date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation.
The key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements.
Detailed description
The primary objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining effects on a range of potential clinical and mechanistic factors: depressive symptoms; immune-metabolic function; activation in the brain's reward and effort processing circuitry using functional magnetic resonance imaging (fMRI); cognitive tasks, focusing on reward processing; and a subset (approximately one-third) of participants will complete L-6-[18F] fluoro-3,4-dihydroxyphenylalnine (18F-DOPA) positron emission tomography (PET).
The secondary objectives are to assess: (1) the degree to which changes in the mechanistic factors are related to changes in interest-activity symptoms of depression resulting from aerobic exercise; (2) whether baseline mechanistic or clinical factors are associated with symptomatic improvement measured by symptom questionnaires following the exercise intervention; (3) whether aerobic exercise-induced changes in the brain circuits underlying cognitive control overlap with those implicated in motivation.
The trial will use an RCT design, with depressed participants randomised to eight weeks of either 45 minutes aerobic exercise of moderate-to-vigorous intensity activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125). The target sample size following expected attrition is N~105 per arm. Participants will complete the trial in staggered cohorts, with no more than six participants per class.
Blood and saliva samples will be taken before the intervention at baseline (between weeks -1 and 0), mid-intervention (week 3 and week 4), and post-intervention (week 9 to week 14) visits, to assess changes in immune-metabolic markers. Blood and saliva samples will also be collected at baseline and post-intervention from approximately 30 healthy controls.
Functional neuroimaging during effort-based decision-making and cognitive control will be taken at baseline and post-intervention. The same functional neuroimaging measures will also be collected at baseline and post-intervention from approximately 30 healthy controls.
Cognitive assessments will be completed online at baseline, every other week during the intervention (week 1, week 3, week 5, week 7), and post-intervention. The same cognitive assessments will also be collected at identical time-windows from approximately 30 healthy controls.
Questionnaire assessments will be completed online at baseline, every other week (week 2, week 4, week 6) and post-intervention (week 9 to 14). The same questionnaire assessments will be collected at baseline and post-intervention from approximately 30 healthy controls.
Accelerometers will measure physical activity continuously at baseline and during the intervention. Fitness testing will provide a measure of cardiovascular fitness at baseline and post-intervention visits. Daily depressive symptoms will be recorded using abbreviated scales using the Neureka smartphone app throughout the intervention. Three-monthly follow up of symptoms/cognition from baseline over six months will assess the durability of effects (week 21 and week 33).
In a subset of participants, approximately one-third of the participants will also complete a positron emission tomography (PET) scan pre-randomisation and at a visit during weeks 4-9 to 14, to assess dopamine synthesis capacity. The same PET scan will also be collected from approximately 30 healthy controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The trial will use a single-site parallel group design with depressed participants randomised to eight weeks of either 45 minutes of aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125).
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exerciseParticipants will be randomised to eight weeks of 45 min aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125). |
| Stretching and relaxation | Active comparator | Other: Stretching and relaxationParticipants will be randomised to eight weeks of 45 min aerobic exercise of stretching and relaxation (control group: three times per week, N=125). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- PHQ9≥12 (moderate depression).
- Current physical activity level below 30 min moderate physical activity, once per week.
- Fluency in English.
- Willingness to undergo the interventions.
- Age 18-60.
Key exclusion criteria (7 listed)
- Medical contraindications to either intervention.
- Neurological illness.
- Past or current diagnosis of psychosis, bipolar disorder, or substance/alcohol use disorder, unless restricted to a depressive episode.
- Unable to complete self-administered cognitive or questionnaire assessments.
- Symptoms or cognitive impairment that would limit capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseThis will be delivered by coaches in a small group class format. Participants will complete the trial in staggered cohorts, with no more than six participants per class. Intervention activities will be tailored to each individual's own ability and fitness level. | Other | Aerobic exercise |
| Stretching and relaxationThis will be delivered by coaches in a small group class format. Participants will complete the trial in staggered cohorts, with no more than six participants per class. Intervention activities will be tailored to each individual's own ability and fitness level. | Other | Stretching and relaxation |
Primary outcome
Patient Health Questionnaire-9 score
Time frame: Post-intervention (week 9 to week 14)
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). Minimum score is 0, maximum score is 27. Higher scores mean a worse outcome.
22 secondary outcomes
Physical activity
Time frame: Baseline assessment period (between weeks -1 and 0) to post-intervention (week 9 to week 14), and follow-up (weeks 21 and 33)
Aerobic capacity: CPET
Time frame: Baseline (between weeks -1 and 0) and post-intervention (week 9 to week 14)
Ecological Momentary Assessment
Time frame: Baseline assessment period (between weeks -1 and 0) to post-intervention (week 9 to week 14)
Inflammatory response (cytokines)
Time frame: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Inflammatory response (genetic markers)
Time frame: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Inflammatory response (flow cytometry immunophenotype)
Time frame: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Neuroendocrine system
Time frame: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Metabolic function
Time frame: Baseline (between weeks -1 and 0), mid-intervention (week 3 or week 4), and post-intervention (week 9 to week 14)
Dopamine synthesis capacity
Time frame: Baseline (between weeks -1 and 0) and post-intervention (week 4-9 to week 14)
Functional magnetic resonance imaging (fMRI) during cognitive tasks
Time frame: Baseline (between weeks -1 and 0) and post-intervention (week 9 to week 14)
Online cognitive tasks
Time frame: During every other week of the intervention (weeks -1/0, week 1, week 3, week 5, week 7, week 9 to week 14)
Depression symptoms
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6)
Anxiety (GAD7 score)
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Anxiety (STAI score)
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Anhedonia (SHAPS score)
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Anhedonia (DARS score)
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Apathy
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Fatigue
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Cognitive impairment
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Self-efficacy
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Self-esteem
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Sleep quality
Time frame: During every other week of the intervention (weeks -1/0, week 2, week 4, week 6, week 9 to week 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. We will share de-identified questionnaire, cognitive, activity, EMA and immune-metabolic data through online repositories. We will share de-identified MRI and PET data on request through managed access agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan P Roiser, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Stretching and relaxation in people with Depression, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Hird, PhD (+44 20 7907 471, e.hird@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 score (time frame: Post-intervention (week 9 to week 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.