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Physical Exercise in Patients With Schizophrenia

Primary Purpose

Schizophrenia, Physical Activity, Telomere Shortening

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Strength physical exercise programme
Normal life
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Date of birth
It will be registered at the beginning of the study in order to calculate the age of the participant.
Sex
It will be registered at the beginning of the study.
Heighth
It will be registered at the beginning of the study in centimeters.
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
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.
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.
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.

Full Information

First Posted
July 17, 2023
Last Updated
August 4, 2023
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05978921
Brief Title
Physical Exercise in Patients With Schizophrenia
Official Title
Effect of Physical Strength Exercise on Telomeric Length as a Marker of Aging and Early Death in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Physical Activity, Telomere Shortening, Premature Aging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The persons in charge of the evaluation of the participants will be unaware of the assignment of the participants.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Subjects in the control group will continue with their normal life and carry out all the activities they have been doing previously.
Intervention Type
Other
Intervention Name(s)
Strength physical exercise programme
Intervention Description
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
Intervention Name(s)
Normal life
Intervention Description
Normal life and carry out all the activities they have been doing previously.
Primary Outcome Measure Information:
Title
Telomere Length
Description
Telomere length will be measured before and after the procedure in kilobases.
Time Frame
Baseline and immediately after the intervention
Secondary Outcome Measure Information:
Title
Date of birth
Description
It will be registered at the beginning of the study in order to calculate the age of the participant.
Time Frame
Baseline
Title
Sex
Description
It will be registered at the beginning of the study.
Time Frame
Baseline
Title
Heighth
Description
It will be registered at the beginning of the study in centimeters.
Time Frame
Baseline
Title
Negative Symptoms
Description
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
Time Frame
Baseline and immediately after the intervention
Title
Fragility
Description
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.
Time Frame
Baseline and immediately after the intervention
Title
Cognition
Description
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.
Time Frame
Baseline and immediately after the intervention
Title
Quality of life
Description
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.
Time Frame
Baseline and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Luis Sánchez González, Phd
Phone
660738949
Email
juanluissanchez@usal.es
Facility Information:
Facility Name
Universidad de Salamanca
City
Salamanca
State/Province
Castilla Y León / Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Luis Sánchez González, Phd
Phone
660738949
Email
juanluissanchez@usal.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon request by e-mail to the principal investigator

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Physical Exercise in Patients With Schizophrenia

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