An interventional study of Supervised multicomponent exercise programme in Severe Mental Disorder, sponsored by Universidad Pablo de Olavide. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Universidad Pablo de Olavide · Not applicable, Interventional, and Treatment
People with severe mental disorder, such as schizophrenia, bipolar disorder or major depression, tend to have poorer physical health and a shorter life expectancy than the general population. Exercise can help, but it is often difficult to keep up over time.
In this study, adults with severe mental disorder took part in a 12-week supervised exercise programme, with two sessions per week. Each session combined stationary cycling, strength exercises on machines, and training of the muscles used for breathing. The programme also included ongoing support and follow-up to help participants keep attending.
Fitness, strength, breathing function and body composition were measured before and after the programme. The researchers also recorded how many participants stayed until the end and how often they attended, and interviewed participants about their experience: what motivated them to join, what helped them continue, and what made it difficult.
The aim is to find out whether this kind of programme is feasible, safe and acceptable for people with severe mental illness, and what changes it produces in their physical health.
Study design and setting
This is a single-arm, 12-week supervised exercise intervention conducted at the Centre for Sport and Physical Performance Research (CIRFD) of Universidad Pablo de Olavide, Seville, Spain. The setting is a university research facility rather than a clinical environment. Participants were recruited in collaboration with three mental health services of differing nature: a community social integration programme (Fundación Pública Andaluza para la Integración Social de Personas con Enfermedad Mental, FAISEM), a mental health day hospital (Hospital Universitario Nuestra Señora de Valme), and a residential therapeutic community (Comunidad Terapéutica de Salud Mental El Tomillar). Participants continued their usual psychiatric treatment throughout the intervention and received no financial compensation.
Intervention structure
The programme consists of 24 sessions delivered twice weekly over 12 weeks. Each session lasts 45-60 minutes and combines three consecutive training blocks: interval aerobic training, resistance training, and inspiratory muscle training. Participants train in groups of up to eight. Each session is supervised by an exercise professional with more than two years of experience working with adults with severe mental illness, a research support technician holding a degree in Sport and Exercise Sciences, and two Sport and Exercise Sciences students. Training loads are adapted at every session to the physical and mental state of each participant.
Aerobic training
Aerobic training is performed on a cycle ergometer (Ergoselect 200K; Ergoline, Bitz, Germany) using a 20-minute interval protocol alternating 1 minute of high intensity with 1 minute of active recovery. Intensity is individualised from peak power output (PPO), determined by an incremental cardiopulmonary exercise test performed at baseline and repeated at week 6 to readjust loads. During testing, intensity is increased progressively until the participant cannot maintain a pedalling cadence of 60-70 rpm; perceived exertion is recorded using the Borg 0-10 scale and cardiopulmonary variables are monitored with a gas analyser (Cosmed K5; Cosmed, Rome, Italy). Load progression is as follows: weeks 1-2 at 65% PPO, weeks 3-4 at 70%, weeks 5-6 at 75%, weeks 7-8 at 80%, weeks 9-10 at 85%, week 11 at 90%, and week 12 at 100% PPO. Recovery intervals are maintained at 30% PPO throughout. Participants sustain a cadence of 60-70 rpm and are monitored in real time by supervisors.
Resistance training
Resistance training consists of a circuit of digitally controlled machines (eGym, Stuttgart, Germany) comprising pec deck, chest press, seated row, shoulder press, lat pulldown, leg press and leg extension. Each session includes three complete circuits (approximately 20 minutes), with 20 seconds of transition between machines and 1 minute of rest between circuits. Loads are individualised through the maximal strength estimation integrated in the eGym system, assessed at baseline and reconfigured periodically. Estimation is performed on each machine using a gamified test in which the participant executes one repetition at maximal force on three occasions, with the highest value used to configure training. Periodisation follows three blocks: weeks 1-4 at 50-60% 1RM, weeks 5-8 at 55-65% 1RM, and weeks 9-12 at 60-70% 1RM, with 10-16 repetitions and a work-to-rest ratio progressing from 30:20 to 45:20 seconds. Technical execution is prioritised and muscular failure is avoided.
Inspiratory muscle training
Inspiratory muscle training is performed with a pressure threshold loading device (POWERbreathe Classic Medium Resistance; POWERbreathe International Ltd., UK), in standing position, consisting of 6 sets of 5 maximal-effort inspirations with complete expirations and 60 seconds of rest between sets. Loads are individualised from maximal inspiratory pressure (MIP), measured with a portable mouth pressure meter (MicroRPM; Micro Medical Inc., Chatham, Kent, UK), with the highest of several maximal inspiratory efforts used to configure training. Progression is as follows: week 1 at 15% MIP, week 2 at 30%, week 3 at 35%, week 4 at 40%, weeks 5-6 at 45%, weeks 7-8 at 50%, weeks 9-10 at 55%, and weeks 11-12 at 60% MIP. MIP is reassessed at week 6 to adjust loads. In contrast to protocols commonly applied in other clinical populations, training frequency is set at two days per week to maximise initial tolerance and adherence in a population characterised by respiratory muscle deconditioning and reduced exercise capacity.
Adherence support strategies
Motivational strategies are integrated throughout the programme, grounded in Self-Determination Theory and classified according to the Behaviour Change Technique Taxonomy v1, with the aim of supporting the basic psychological needs of competence, autonomy and relatedness. These include: an individualised step challenge based on daily monitoring with activity wristbands (Xiaomi Mi Band 4) and weekly personalised step goals derived from a 10-day rolling window; weekly educational and motivational content delivered by instant messaging the day before each session; a mid-intervention peer support group meeting facilitated by staff acting solely as moderators; continuous bidirectional communication between professionals and participants; systematic positive feedback during sessions and remote contacts; advance planning through a fixed structure of schedules, locations and session duration; promotion of social support through the group format and collaboration with mental health services; intermediate fitness assessments to monitor progress and make gains visible; active follow-up after any absence through direct contact to identify barriers and offer support; continuous supervision by exercise professionals; and individualised, flexible adaptation of training according to clinical status and exercise response.
Assessment schedule
Assessments are conducted at baseline (two weeks before the intervention), at mid-intervention (week 6, to readjust training loads), and after completion of the 12-week programme. Semi-structured interviews exploring participants' experience of the programme are conducted at the end of the intervention with participants who completed the programme and with those who withdrew and could be contacted.
Reporting and methodological framework
The intervention was designed following the PADEX guideline for promoting exercise adherence in people with chronic conditions. Reporting of the intervention follows the Consensus on Exercise Reporting Template (CERT). Reporting of study findings follows the TREND statement for non-randomised evaluations and, for the qualitative component, the Reflexive Thematic Analysis Reporting Guidelines
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Universidad Pablo de Olavide is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 12-week supervised multicomponent exercise programme delivered twice weekly (24 sessions, 45-60 minutes each) in groups of up to eight, at a university sport and exercise research facility. Each session combines three consecutive blocks: interval aerobic training on a cycle ergometer individualised to peak power output, resistance training on digitally controlled machines individualised to estimated maximal strength, and inspiratory muscle training with a pressure threshold device individualised to maximal inspiratory pressure. Loads progress throughout the programme and are reassessed at week 6. Behaviour change strategies are applied to support adherence.
Other: Supervised multicomponent exercise programme
Twelve-week supervised programme delivered twice weekly (24 sessions of 45-60 minutes) in groups of up to eight participants, at a university sport and exercise research facility rather than a clinical setting. What distinguishes this intervention is the combination of three training components within every session, delivered consecutively: (1) 20 minutes of interval aerobic training on a cycle ergometer, alternating 1 minute of high intensity with 1 minute of active recovery, individualised to peak power output and progressing from 65% to 100% PPO; (2) 20 minutes of resistance training as a three-round circuit on seven digitally controlled machines, individualised to estimated maximal strength and periodised from 50-60% to 60-70% 1RM; and (3) inspiratory muscle training using a pressure threshold loading device, 6 sets of 5 maximal inspirations, individualised to maximal inspiratory pressure and progressing from 15% to 60% MIP at a frequency of two days per week rather than the daily
Maximal inspiratory pressure (MIP)
Maximal inspiratory pressure, an index of inspiratory muscle strength, measured with a portable mouth pressure meter (MicroRPM; Micro Medical Inc., Chatham, Kent, UK). Participants perform repeated maximal inspiratory efforts from residual volume in standing position, and the highest value obtained is recorded. Values are expressed in cmH2O. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Forced vital capacity (FVC)
Forced vital capacity, measured by spirometry (microQuark; COSMED, Rome, Italy) following standard procedures. Participants perform maximal forced expiratory manoeuvres and the highest acceptable value is recorded. Values are expressed in litres. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Peak oxygen uptake (VO2 peak)
Peak oxygen uptake, measured during an incremental cardiopulmonary exercise test on a cycle ergometer (Ergoselect 200K; Ergoline, Bitz, Germany) with breath-by-breath gas analysis (K5; COSMED, Rome, Italy). Intensity is increased progressively until the participant cannot maintain a pedalling cadence of 60-70 rpm. Values are expressed in mL/kg/min. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Handgrip strength
Maximal isometric handgrip strength, measured with a hand dynamometer (TKK; Takei Scientific Instruments Co. Ltd., Niigata, Japan) in standing position with the arm extended alongside the body. Participants perform repeated maximal attempts and the highest value is recorded. Values are expressed in kilograms. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Body composition assessed by dual-energy X-ray absorptiometry
Whole-body composition, measured by dual-energy X-ray absorptiometry (Horizon A; Hologic Inc., Marlborough, MA, USA) following standard positioning and analysis procedures. Outcomes include total and regional fat mass (kg), lean mass (kg), body fat percentage, and bone mineral density (g/cm2). Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Peak expiratory flow (PEF)
Peak expiratory flow, measured by spirometry (microQuark; COSMED, Rome, Italy) during maximal forced expiratory manoeuvres. The highest acceptable value is recorded. Values are expressed in litres per minute. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Physical activity and sedentary behaviour
Physical activity and sedentary behaviour, measured objectively with a triaxial accelerometer (ActiGraph) worn continuously over several consecutive days under standardised wear-time criteria. Outcomes include time spent in moderate-to-vigorous physical activity (minutes/day), light physical activity (minutes/day), sedentary time (minutes/day) and daily step count. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Retention rate
Proportion of enrolled participants who completed the 12-week intervention, calculated as the number of participants completing the post-intervention assessment divided by the total number of participants enrolled. Withdrawal is defined as explicit communication of discontinuation of participation.
Time frame: Through the 12-week intervention period
Session attendance rate
Proportion of scheduled sessions attended, calculated as the number of sessions attended divided by the total number of sessions scheduled. Attendance is recorded as physical presence at the session, irrespective of the degree of completion of the training content. Reasons for non-attendance and for withdrawal are also recorded.
Time frame: Through the 12-week intervention period
Adverse events
Number and nature of adverse events occurring during the intervention period, defined as any untoward medical occurrence requiring medical attention, hospitalisation or permanent discontinuation of participation. Musculoskeletal complaints or discomfort of mild or moderate severity attributable to the exercise sessions are recorded separately. Events are assessed for their relationship to the intervention.
Time frame: Through the 12-week intervention period
Acceptability of the intervention
Acceptability of the intervention, explored through individual semi-structured interviews conducted at the end of the intervention with participants who completed the programme and with those who withdrew and could be contacted. Interviews address perceptions of exercise as part of treatment, motivation for participation, and experiences and perceived benefits. Participants are also asked to rate, on a scale from 1 to 10, the extent to which they would recommend the intervention to other people with severe mental illness.
Time frame: At the end of the 12-week intervention
Peak power output
Peak power output achieved during an incremental cardiopulmonary exercise test on a cycle ergometer (Ergoselect 200K; Ergoline, Bitz, Germany), defined as the highest workload sustained before the participant was unable to maintain a pedalling cadence of 60-70 rpm. Values are expressed in watts. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Walking capacity (Incremental Shuttle Walk Test)
Walking capacity, assessed with the Incremental Shuttle Walk Test, in which participants walk between two markers set 10 metres apart at a pace dictated by audio signals of progressively increasing frequency. The test ends when the participant cannot reach the marker in time or is unable to continue. The total distance covered is recorded in metres. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Lower-limb functional strength (5-repetition Sit-to-Stand test)
Lower-limb functional strength, assessed with the 5-repetition Sit-to-Stand test. Participants rise from a seated position to full standing and return to sitting five times as quickly as possible, with arms crossed over the chest. The time taken to complete the five repetitions is recorded in seconds. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Body composition assessed by bioelectrical impedance analysis
Body composition, measured by multifrequency bioelectrical impedance analysis (InBody 770; InBody Co. Ltd., Seoul, South Korea) under standardised conditions. Outcomes include fat mass (kg), skeletal muscle mass (kg) and body fat percentage. This method is used as a secondary approach to body composition assessment alongside dual-energy X-ray absorptiometry. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
Isometric strength
Maximal isometric strength of the knee extensors (quadriceps), measured with a handheld dynamometer (Lafayette Instrument Company, Lafayette, IN, USA). Participants perform maximal voluntary isometric contractions against the dynamometer in a standardised seated position with the knee flexed, and the highest value of several attempts is recorded. Values are expressed in newtons. Change is calculated as the difference between post-intervention and baseline assessment.
Time frame: Baseline and immediately after the 12-week intervention
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Ran from Sep 2023 to primary completion in Dec 2023, 3 months.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 3 months is below that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Universidad Pablo de Olavide