Physical Exercise in Patients With First Psychotic Episode
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be at least 18 years of age
Having experienced a first psychotic episode in the last 3 years
Disqualifiers
are unable to read and understand the patient information sheet and sign the informed consent form.
Trial design
Design model
Parallel
Treatments tested in this trial
Other: Strength physical exercise programme
Other intervention12 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 interventionDescription: Normal life and carry out all the activities they have been doing previously.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental: Intervention groupExperimental treatment 1 intervention
Group B: Sham Comparator: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Telomere Length
Telomere length will be measured before and after the procedure in kilobases.
Time frame
Baseline and immediately after the interventionSecondary outcomes
1
Fragility
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.
Time frame
Baseline and immediately after the intervention2
Quality of life
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.
Time frame
Baseline and immediately after the intervention3
Differential plasma profile
Inflammatory proteins
Time frame
Baseline and immediately after the interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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