Physical Exercise in Patients With First Psychotic Episode

NCT07207538 | Not Yet Recruiting

• 1 other identifier: ExerciseFirstPsychoticEpisode
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Telomere Length; Exercise; First Episode Psychosis (FEP)

Keywords

Exercise; Telomere length; Aging

Outcome Measures

Primary Outcomes (1)

• Telomere Length

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

  Baseline and immediately after the intervention

Secondary Outcomes (3)

• Fragility

  Baseline and immediately after the intervention

• Quality of life

  Baseline and immediately after the intervention

• Differential plasma profile

  Baseline and immediately after the intervention

Study Arms (2)

Experimental: Intervention group

EXPERIMENTAL

n additional strength training programme will be carried out for 12 weeks with 2 sessions per week. The sessions will last approximately 50 minutes and will be divided into 3 distinct parts: The first part will consist of a warm-up with a part of aerobic exercise that will last approximately 15 minutes. This will be followed by the main part of strength training with a circuit of 6 exercises (3 series x 12 repetitions) which will last approximately 25 minutes. Finally, there will be a cool down phase with breathing exercises to allow people to recover.

Other: Other: Strength physical exercise programme

Sham Comparator: Control group

SHAM COMPARATOR

Subjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.

Other: Other: Normal life

Interventions

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.

Experimental: Intervention group

Other: Normal life OTHER

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

Sham Comparator: Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Juan Luis Sánchez González Phd

CONTACT

+34 660738949; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The persons in charge of the evaluation of the participants will be unaware of the assignment of the participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Juan Luis Sánchez González

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09