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NCT Number: NCT07207538

Physical Exercise in Patients With First Psychotic Episode

Justification: Patients with first-episode psychosis are at increased risk of premature ageing and early mortality, associated with telomere shortening and increased inflammatory markers. Physical exercise has shown protective effects in the general population, but there are no intervention studies in this population.

Objective: To evaluate the effect of a strength training programme on telomere length and other markers of cellular ageing in people with a first episode of psychosis.

Material and methods: Quasi-experimental study with patients aged 18-35 years included in the PRINT programme (Salamanca). Standard treatment will be compared with standard treatment plus a 12-week strength training programme. Telomere length (qPCR), inflammatory and senescence markers (proteomics), body composition, frailty and quality of life will be analysed.

Applicability: The results could support the inclusion of physical exercise programmes as a complementary intervention in early psychosis care, promoting overall health, quality of life and reducing the gap in life expectancy compared to the general population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be at least 18 years of age
  • Having experienced a first psychotic episode in the last 3 years

Exclusion criteria

  • are unable to read and understand the patient information sheet and sign the informed consent form.

Treatment and study plan

Other: Strength physical exercise programme

Other

12 multi-joint strength exercises will be developed. Participants will be taught the rating scale of perceived exertion (RPE) based on the number of repetitions in reserve (RIR). Participants will be asked that during the performance of each of the exercises they must perceive an effort between 7-8 within the overall score of the scale (0-10; 0 = no effort at all and 10 = cannot perform one more repetition, i.e. maximal effort). When subjects perform the 12 repetitions with lower perceived exertion than the set effort in two consecutive sessions with full range of motion the training load will be increased by about 2-10% following the American College of Sports Medicine guidelines and reassessed using the RIR-based RPE. Patients in the usual treatment group will continue to participate in their existing rehabilitation programmes, but will not be included in the strength training programme.

Other: Normal life

Other

Description: Normal life and carry out all the activities they have been doing previously.

Primary outcomes

  1. Telomere Length

    Time frame: Baseline and immediately after the intervention

    Telomere length will be measured before and after the procedure in kilobases.

Secondary outcomes

  1. Fragility

    Time frame: Baseline and immediately after the intervention

    Fragility will be measured using the Short Physical Performance Battery scale (SPPB). SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with possible sarcopenia but no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. Persons with a score of 2 or lower who have sarcopenia, potential cachexia, and mobility disability are determined to be disabled.

  2. Quality of life

    Time frame: Baseline and immediately after the intervention

    Quality of life will be assessed using the EuroQuality of Life (EQ-5D-5L scale). This scale is numbered from 0 to 100. • 100 means the best health you can imagine. 0 means the worst health you can imagine.

  3. Differential plasma profile

    Time frame: Baseline and immediately after the intervention

    Inflammatory proteins

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Luis Sánchez González Phd

CONTACT

[email protected]

+34 660738949

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Impact of Physical Exercise on Telomere Length and Other Markers of Premature Ageing in First-episode Psychosis.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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