Aerobic, Resistance and Inspiratory Muscle Training in Adults With Severe Mental Illness

NCT07758049 | Completed

• 2 other identifiers: 21/3-2PID2020-118262RB-I00
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

People with severe mental illness, 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 illness 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.

Conditions

Severe Mental Disorder

Keywords

Exercise; Severe Mental Illness; Schizophrenia; Adherence; Fitness; Body Composition; Aerobic Training; Resistance Training; Inspiratory Muscle Training

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline and immediately after the 12-week intervention

Secondary Outcomes (10)

• Physical activity and sedentary behaviour

  Baseline and immediately after the 12-week intervention

• Retention rate

  Through the 12-week intervention period

• Session attendance rate

  Through the 12-week intervention period

• Adverse events

  Through the 12-week intervention period

• Acceptability of the intervention

  At the end of the 12-week intervention

Study Arms (1)

Multicomponent exercise intervention

EXPERIMENTAL

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

Interventions

Supervised multicomponent exercise programme OTHER

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

Multicomponent exercise intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical diagnosis of severe mental illness 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Pablo de Olavide: lead

Study Sites (1)

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

Seville, SEVILLA, 41013, Spain

Location

MeSH Terms

Conditions

Mental Disorders; Motor Activity; Schizophrenia

Condition Hierarchy (Ancestors)

Behavior; Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (designated)

Model Details: Single-arm design. All enrolled participants received the same 12-week supervised multicomponent exercise intervention. There is no control or comparison group and no randomisation.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: September 9, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)