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Physical Exercise in Patients With Schizophrenia

Effect of Physical Strength Exercise on Telomeric Length as a Marker of Aging and Early Death in Patients With Schizophrenia

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05978921
Enrollment
40
Registered
2023-08-07
Start date
2024-03-01
Completion date
2024-05-01
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity, Premature Aging, Schizophrenia, Telomere Shortening

Brief summary

Randomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal age, of both sexes, recruited in the mental health clinics of the Salamanca University Assistance Complex and who will be randomly distributed into two groups (intervention and control). The main objective of the study is to determine the effect of physical exercise on telomere size in patients diagnosed with schizophrenia. As secondary objectives in this group of patients we will try to: Evaluate the influence of strength training on cognition and negative symptoms of schizophrenia. To quantify the impact of strength training on frailty. To determine the effect of strength training on quality of life. To study the possible correlation between physical parameters (frailty) and telomere length. To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the maintenance of telomere length.

Interventions

OTHERStrength physical exercise programme

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.

OTHERNormal life

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

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

The persons in charge of the evaluation of the participants will be unaware of the assignment of the participants.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* be at least 18 years of age * have been diagnosed with schizophrenia for at least 5 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Telomere LengthBaseline and immediately after the interventionTelomere length will be measured before and after the procedure in kilobases.

Secondary

MeasureTime frameDescription
SexBaselineIt will be registered at the beginning of the study.
HeighthBaselineIt will be registered at the beginning of the study in centimeters.
Negative SymptomsBaseline and immediately after the interventionNegative symptoms of the disease will be measured and assessed using the Brief Negative Symptom Scale (BNSS). The BNSS is comprised of 13 questions organized into 6 subscales that assess anhedonia, distress, asociality, avolition, blunted affect, and alogia. Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe
Date of birthBaselineIt will be registered at the beginning of the study in order to calculate the age of the participant.
CognitionBaseline and immediately after the interventionCognition will be measured using the Brief Assessment of Cognition in Schizophrenia (BACS).The maximum and minimum score on the Brief Assessment of Cognition in Schizophrenia (BACS) is 100 points and the minimum possible score is 0 points. The scoring scale is based on the performance of a normative reference group, where the mean is set at 100 and the standard deviation at 15. Thus, a score of 100 indicates average performance within the normative population, while a higher score would be considered above average and a lower score below average.
Quality of lifeBaseline and immediately after the interventionQuality 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.
FragilityBaseline and immediately after the interventionFragility 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.

Countries

Spain

Contacts

Primary ContactJuan Luis Sánchez González, Phd
juanluissanchez@usal.es660738949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026