Telomere LengthNCT07207538
Physical Exercise in Patients With First Psychotic Episode
A study testing Other: Strength physical exercise programme and Other: Normal life in people with Telomere Length and Exercise, run by University of Salamanca.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telomere Length, Exercise, First Episode Psychosis (FEP)
- What is being tested?
- Other: Strength physical exercise programme and Other: Normal life
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- Having experienced a first psychotic episode in the last 3 years
Who cannot join
- are unable to read and understand the patient information sheet and sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Physical Exercise on Telomere Length and Other Markers of Premature Ageing in First-episode Psychosis.
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.
Read more
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)
- Being tested
- Other: Strength physical exercise programme, Other: Normal life
- Keywords
- Exercise, Telomere length, Aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Strength physical exercise programmeOther
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 lifeOther
Description: Normal life and carry out all the activities they have been doing previously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Other: Normal life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere Length
Telomere length will be measured before and after the procedure in kilobases.
Measured: Baseline and immediately after the intervention
Secondary outcomes (3)
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.
Measured: Baseline and immediately after the intervention
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.
Measured: Baseline and immediately after the intervention
Differential plasma profile
Inflammatory proteins
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telomere LengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Luis Sanchez Gonzalez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207538
- Sponsor's protocol ID
- ExerciseFirstPsychoticEpisode
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request by e-mail to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Exercise on Telomere Length and Other Markers of Premature Ageing in First-episode Psychosis.
- ClinicalTrials.gov ID
- NCT07207538
- Acronym / sponsor ID
- ExerciseFirstPsychoticEpisode
- Conditions
- Telomere Length, Exercise, First Episode Psychosis (FEP)
- Keywords
- Exercise, Telomere length, Aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Other: Other: Strength physical exercise programmen 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. |
| Sham Comparator: Control group | Sham comparator | Other: Other: Normal lifeSubjects in the control group will continue with their normal life and carry out all the activities they have been doing previously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be at least 18 years of age
- Having experienced a first psychotic episode in the last 3 years
Key exclusion criteria (1 listed)
- are unable to read and understand the patient information sheet and sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Strength physical exercise programme12 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 | Experimental: Intervention group |
| Other: Normal lifeDescription: Normal life and carry out all the activities they have been doing previously. | Other | Sham Comparator: Control group |
Primary outcome
Telomere Length
Time frame: Baseline and immediately after the intervention
Telomere length will be measured before and after the procedure in kilobases.
3 secondary outcomes
Fragility
Time frame: Baseline and immediately after the intervention
Quality of life
Time frame: Baseline and immediately after the intervention
Differential plasma profile
Time frame: Baseline and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Undecided. Upon request by e-mail to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Other: Strength physical exercise programme and Other: Normal life in people with Telomere Length and Exercise, run by University of Salamanca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Luis Sánchez González Phd (+34 660738949, juanluissanchez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere Length (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.