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Can exercise boost fitness and breathing in severe mental illness?

NCT ID NCT07758049

Symptom relief Sponsor: Universidad Pablo de Olavide Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests a 12-week supervised exercise program for adults with severe mental illness, such as schizophrenia, bipolar disorder, or major depression. The program combines cycling, strength training, and breathing exercises in twice-weekly sessions. Researchers will measure changes in fitness, strength, breathing, and body composition, and also assess how well participants stick with the program and their experiences. The goal is to see if this type of program is feasible, safe, and acceptable, and what physical health benefits it may offer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A supervised multicomponent exercise program combining interval aerobic training, resistance training, and inspiratory muscle training, delivered twice weekly for 12 weeks.
What this could lead to
If successful, this program could offer a practical, acceptable way to improve physical health and quality of life for people with severe mental illness, potentially reducing their risk of early death.
What could go wrong
This is a small, single-arm study without a comparison group, so any benefits seen might not be solely due to the exercise. Adherence may be challenging, and results may not apply to all individuals with severe mental illness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

49 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Medical diagnosis of severe mental disorder according to ICD-10 criteria * Aged between 18 and 65 years * Clinical stability confirmed by the participant's mental health professionals * Physically able to perform exercise * Able to travel to the intervention site * Written informed consent Exclusion Criteria: * Acute psychiatric decompensation at the time of enrolment * Medical condition contraindicating exercise participation, including uncontrolled cardiovascular disease * Inability to complete baseline assessments * Currently participating in another structured exercise programme

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Conditions

The condition(s) this trial relates to.

mental disorder Motor Activity psychiatric disorder Schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe mental disorder

Contacts and locations

Locations

  • Centro de Investigación en Rendimiento Físico y Deportivo (CIRFD), Universidad Pablo de Olavide

    Seville, SEVILLA, 41013, Spain

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