SchizophreniaNCT05978921
Physical Exercise in Patients With Schizophrenia
A study testing Strength physical exercise programme and Normal life in people with Schizophrenia and Physical Activity, run by University of Salamanca at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Physical Activity, Telomere Shortening
- What is being tested?
- Strength physical exercise programme and Normal life
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- have been diagnosed with schizophrenia for at least 5 years
Who cannot join
- are unable to read and understand the patient information sheet and sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Salamanca
Salamanca, Castilla Y León / Salamanca, 37007
Juan Luis Sánchez González, Phd, 660738949, juanluissanchez@usal.es
About this study
Official title: 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.
Read more
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
- Being tested
- Strength physical exercise programme, Normal life
- Medical subject headings
- Schizophrenia, Motor Activity, Aging, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength physical exercise programmeOther
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 lifeOther
Normal life and carry out all the activities they have been doing previously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere Length
Telomere length will be measured before and after the procedure in kilobases.
Measured: Baseline and immediately after the intervention
Secondary outcomes (7)
Date of birth
It will be registered at the beginning of the study in order to calculate the age of the participant.
Measured: Baseline
Sex
It will be registered at the beginning of the study.
Measured: Baseline
Heighth
It will be registered at the beginning of the study in centimeters.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Luis Sanchez Gonzalez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978921
- Sponsor's protocol ID
- ExerciseSchizophrenia
- Status last verified
- Jan 2024
- First submitted
- 17 Jul 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request by e-mail to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Strength Exercise on Telomeric Length as a Marker of Aging and Early Death in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05978921
- Acronym / sponsor ID
- ExerciseSchizophrenia
- Conditions
- Schizophrenia, Physical Activity, Telomere Shortening, Premature Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Strength physical exercise programmeAn 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. |
| Control group | Sham comparator | Other: Normal lifeSubjects in the control group will continue with their normal life and carry out all the activities they have been doing previously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be at least 18 years of age
- have been diagnosed with schizophrenia for at least 5 years
Key exclusion criteria (1 listed)
- are unable to read and understand the patient information sheet and sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength physical exercise programme12 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. | Other | Intervention group |
| Normal lifeNormal life and carry out all the activities they have been doing previously. | Other | Control group |
Primary outcome
Telomere Length
Time frame: Baseline and immediately after the intervention
Telomere length will be measured before and after the procedure in kilobases.
7 secondary outcomes
Date of birth
Time frame: Baseline
Sex
Time frame: Baseline
Heighth
Time frame: Baseline
Negative Symptoms
Time frame: Baseline and immediately after the intervention
Fragility
Time frame: Baseline and immediately after the intervention
Cognition
Time frame: Baseline and immediately after the intervention
Quality of life
Time frame: Baseline and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided. Upon request by e-mail to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength physical exercise programme and Normal life in people with Schizophrenia and Physical Activity, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Luis Sánchez González, Phd (660738949, juanluissanchez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere Length (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.