Physical Exercise in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05978921
• Other study ID #: ExerciseSchizophrenia
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: University of Salamanca
• Contact: Juan Luis Sánchez González, Phd
• Phone: 660738949
• Email: juanluissanchez[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging, Premature
• Physical Activity
• Premature Aging
• Schizophrenia
• Telomere Shortening

Intervention

Other:
• Strength 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.
• Normal life
Normal life and carry out all the activities they have been doing previously.

Locations

Country	Name	City	State
Spain	Universidad de Salamanca	Salamanca	Castilla Y León / Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere Length	Telomere length will be measured before and after the procedure in kilobases.	Baseline and immediately after the intervention
Secondary	Date of birth	It will be registered at the beginning of the study in order to calculate the age of the participant.	Baseline
Secondary	Sex	It will be registered at the beginning of the study.	Baseline
Secondary	Heighth	It will be registered at the beginning of the study in centimeters.	Baseline
Secondary	Negative Symptoms	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	Baseline and immediately after the intervention
Secondary	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.	Baseline and immediately after the intervention
Secondary	Cognition	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.	Baseline and immediately after the intervention
Secondary	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.	Baseline and immediately after the intervention