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Physical Exercise in Patients With Schizophrenia

Not Applicable
Not yet recruiting
Conditions
Schizophrenia
Premature Aging
Physical Activity
Telomere Shortening
Interventions
Other: Normal life
Other: Strength physical exercise programme
Registration Number
NCT05978921
Lead Sponsor
University of Salamanca
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control groupNormal lifeSubjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.
Intervention groupStrength physical exercise programmeAn 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.
Primary Outcome Measures
NameTimeMethod
Telomere LengthBaseline and immediately after the intervention

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

Secondary Outcome Measures
NameTimeMethod
SexBaseline

It will be registered at the beginning of the study.

CognitionBaseline and immediately after the intervention

Cognition 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.

FragilityBaseline 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.

Date of birthBaseline

It will be registered at the beginning of the study in order to calculate the age of the participant.

Quality of lifeBaseline 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.

HeighthBaseline

It will be registered at the beginning of the study in centimeters.

Negative SymptomsBaseline and immediately after the intervention

Negative 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

Trial Locations

Locations (1)

Universidad de Salamanca

🇪🇸

Salamanca, Castilla Y León / Salamanca, Spain

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