Physical Exercise in Patients With Schizophrenia

NCT ID: NCT05978921

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-05-01

Brief Summary

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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

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Conditions

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Schizophrenia Physical Activity Telomere Shortening Premature Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Strength physical exercise programme

Intervention Type 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.

Control group

Subjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.

Group Type SHAM_COMPARATOR

Normal life

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Normal life

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Juan Luis Sanchez Gonzalez

Principal Investigator. Juan Luis Sánchez González

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Salamanca

Salamanca, Castilla Y León / Salamanca, Spain

Site Status

Countries

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Spain

Central Contacts

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Juan Luis Sánchez González, Phd

Role: CONTACT

660738949

Facility Contacts

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Juan Luis Sánchez González, Phd

Role: primary

660738949

Other Identifiers

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ExerciseSchizophrenia

Identifier Type: -

Identifier Source: org_study_id

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