Physical Exercise in Patients With Schizophrenia

NCT05978921 | Unknown

• 1 other identifier: ExerciseSchizophrenia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Physical Activity; Telomere Shortening; Premature Aging

Outcome Measures

Primary Outcomes (1)

• Telomere Length

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

  Baseline and immediately after the intervention

Secondary Outcomes (7)

• Date of birth

  Baseline

• Sex

  Baseline

• Heighth

  Baseline

• Negative Symptoms

  Baseline and immediately after the intervention

• Fragility

  Baseline and immediately after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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.

Other: Normal life

Interventions

Strength physical exercise programme OTHER

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.

Intervention group

Normal life OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, Castilla Y León / Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Schizophrenia; Motor Activity; Aging, Premature

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Juan Luis Sánchez González, Phd

CONTACT

660738949; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The persons in charge of the evaluation of the participants will be unaware of the assignment of the participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Juan Luis Sánchez González

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 7, 2023
• Study Start: March 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

ES (1)