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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Physical Activity; Telomere Shortening; Premature Aging
• Intervention / Treatment: Other: Strength physical exercise programme; Other: Normal life

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Luis Sánchez González, Phd; Phone Number: 660738949; Email: juanluissanchez@usal.es

Study Locations

• Spain
  • Castilla Y León / Salamanca
    • Salamanca, Castilla Y León / Salamanca, Spain, 37007
      • Universidad de Salamanca
      • Contact: Juan Luis Sánchez González, Phd; Phone Number: 660738949; Email: juanluissanchez@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; An 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.	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.
Sham Comparator: Control group; Subjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.	Other: Normal life; Normal life and carry out all the activities they have been doing previously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telomere Length	Telomere length will be measured before and after the procedure in kilobases.	Baseline and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Date of birth	It will be registered at the beginning of the study in order to calculate the age of the participant.	Baseline
Sex	It will be registered at the beginning of the study.	Baseline
Heighth	It will be registered at the beginning of the study in centimeters.	Baseline
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Aging, Premature
• Other Study ID Numbers: ExerciseSchizophrenia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon request by e-mail to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No