Patients With Chronic SchizophreniaLEST-CSchizoNCT07183969
The Effectiveness of Lower Extremity Strength Training
A study testing lower limb muscle strength training program in people with Patients With Chronic Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The increase in chronic schizophrenia patients with sarcopenia is currently an important healthcare issue in Taiwan and requires enhanced prevention and progress. Therefore, the purpose of this study was to understand the prevalence of sarcopenia in patients with chronic schizophrenia and to explore the effect of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Patients With Chronic Schizophrenia
- What is being tested?
- lower limb muscle strength training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2024to 26 Jan 2025
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Suitable for participation in this study as assessed by the attending physician.
- (2) After explaining the purpose of the study and the study process, family members and study subjects were asked to agree to participate in the study and to complete the consent form for signature.
Who cannot join
- (1) Those who are unable to walk unaided.
- (2) Severe structural disability that prevents the performance of lower extremity training.
- (3) Those with severe psychiatric symptoms that prevent them from concentrating and following instructions.
- (4)Participation in a lower extremity muscle training program or intervention within one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Lower Extremity Strength Training on the Physical Performance of Patients With Chronic Schizophrenia With Sarcopenia.
The increase in chronic schizophrenia patients with sarcopenia is currently an important healthcare issue in Taiwan and requires enhanced prevention and progress. Therefore, the purpose of this study was to understand the prevalence of sarcopenia in patients with chronic schizophrenia and to explore the effect of lower limb strength training on the physical functional performance of patients with chronic schizophrenia and sarcopenia. This study adopted a quasi-experimental design method, and the research process was divided into two stages. In the first stage, the SARC-CalF questionnaire was used to initially screen suspected chronic schizophrenia patients in a psychiatric hospital in central Taiwan. For sarcopenia cases, the skeletal muscle mass index (Skeletal Muscle Mass index) of suspected sarcopenia cases is further compared with the body composition analyzer (Inboby) to confirm the diagnosis of sarcopenia. Statistical analysis of the prevalence of sarcopenia in patients with chronic schizophrenia. In the second phase of the study, 4 chronic disease areas (two chronic disease areas for men and women) were randomly divided into experimental groups and control groups. The experimental group received a 16-week lower limb muscle strength training program, while the control group received routine care. The two groups conducted one pre-test and two post-tests, and the measurement content included physical function performance (Short Physical Performance Battery (SPPB), sarcopenia quality of life (SarQoL), and fall incidence). It is expected that the development of a set of non-pharmacological care measures will help patients in chronic psychiatric wards to become independent and slow down the progression of sarcopenia.
Read the detailed description
Methods:
The purpose of this study was to investigate the effects of lower extremity muscle training on the functional performance of sarcopenia in patients with chronic schizophrenia . The study will to examine the effectiveness of a 16-week lower extremity muscle training program on the functional performance of of sarcopenia in patients with chronic schizophrenia Sample size calculation. Sample size was calculated using G*Power 3.1.9.2 software, with reference to a randomized controlled study (Nygård et al., 2023) on the integration of plyometric training into the long-term collaborative care of people with psychosis. ANOVA: Repeated measures, between factors, Effect size: 0.5, α = 0.05, Power = 0.8, 2 groups, 3 measurements per group, results showed that at least 24 cases were enrolled in each group. However, in order to increase the statistical validity and to take into account the possibility of dropout or low attendance, the default attrition rate was 25%, with 30 cases in each group. Considering that the ratio of males to females with psychosis is 1.4:1, the sample size of this study is estimated to be 40 cases in each of the experimental and control groups (24 males and 16 females in each group), making a total of 80 subjects.
Data analysis:
In this study, the data were collected and compiled, coded and entered into a computer file, and processed using the SPSS for windows version 22.0 statistical package for statistical analysis, with the significant level set at α=0.05. The data were analyzed and analyzed using the SPSS for windows version 22.0 statistical software.
Steps Based on the screening results, eight chronic wards with a high number of myasthenia gravis chronic psychosis cases were selected and divided into two groups according to gender (24 males and 16 females in each group), which were randomly assigned to the experimental and control groups by drawing lots with an opaque envelope by a non-study project staff member (a nurse practitioner supervisor). After explaining the purpose of the study and the study process to the subjects, and after the subjects had agreed to participate in the study, they were asked to sign the consent form by telephone with their family members (note the date and time of the telephone call for family members' consent). After explaining the purpose of the study and the study process to the subjects, and after the subjects had agreed to participate in the study, they were asked to sign the consent form by telephone with their family members (note the date and time of the telephone call for family members' consent).
A total of three outcome measures were assessed at pre-intervention, 8 weeks post-intervention, and 16 weeks post-intervention. In order to avoid measurement bias, the measurements in each group were performed by the same tester (facilitator).
Total of 16 weeks of lower extremity strength training was implemented in the experimental group. The training content was designed with reference to the literature and in discussion with senior psychiatric nursing staff, an ageing physical fitness instructor, and the director of the rehabilitation department, and was attempted to be taught in the community to elderly people with sarcopenia and in a chronic psychiatric ward in central China, to confirm that it was feasible to implement and that it was expected to be effective. The total number of interventions in this study was 48 (3 per week, each lasting approximately 1 hour for 16 weeks). In the week prior to the study intervention, the same professional physical fitness instructor and facilitator came to the lobby of the experimental group ward to teach and instruct the subjects on the lower limb plyometric exercises 3 times a week for 1 hour, for a total of 3 sessions. 16 weeks of the lower limb plyometric interventions were conducted by the same professional physical fitness instructor for the female ward and by the same facilitator for the male ward.
In the experimental wards, lower extremity muscle training was performed once every 3 days per week at a time slot selected by the facilitator, who assessed with the ward nursing staff the appropriateness of the day's vital signs and physical condition for performing the lower extremity training. Because of the benefits of lower extremity strength training in preventing sarcopenia and falls, after the completion of this study, the control group will be provided with instruction and guidance on lower extremity strength training maneuvers, 3 times per week for 1 hour each time, for a total of 3 times, and will be encouraged to continue to perform the exercises in their daily lives.
- Conditions
- Patients With Chronic Schizophrenia
- Being tested
- lower limb muscle strength training program
- Keywords
- Lower extremity strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower limb muscle strength training programOther
Each plyometric training session consists of warm-up stretching, lower limb plyometrics, and gentle stretching.
Warm-up stretching, there are 6 movements, push the window, pull the rope, hands up, stretch from side to side, lift one foot and open and close both feet. Do 10 repetitions of each movement, 2 rounds, and keep breathing normally for a few repetitions.
Lower Extremity Plyometrics: 3 rounds of 6 plyometrics with 1 minute of recovery time between each round. The six lower body plyometrics exercises are performed by gradually increasing the load in a manner that increases the number of seconds the exercise is held.
Gentle Stretching: Continuous training of muscles makes them tense, stretching can lengthen muscle fibers, increase muscle elasticity, and improve blood circulation to eliminate post-training fatigue (H.K. Chen, 2022). Perform each gentle stretching movement left and right once, hold for 30 seconds each time, and keep breathing normally (no shutting up of breath).
| Study group | Role | What they receive |
|---|---|---|
| experimental groups | Experimental | 16-week lower limb muscle strength training program Receives: Other: lower limb muscle strength training program |
| control groups | No intervention | received routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
Chair Stand Test' Chair Stand Test、Balance tests、 Gait speed test
Measured: baseline、8weeks、16weeks
The Sarcopenia Quality of Life Questionnaire (SarQoL-TW)
Chinese version of the Taiwan version
Measured: baseline、8weeks、16weeks
fall incidence
medical records
Measured: baseline、8weeks、16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start20 Sep 2024
- Primary completion16 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Chronic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Tzu Shih, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183969
- Sponsor's protocol ID
- CShih
- Acronym
- LEST-CSchizo
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 無
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Lower Extremity Strength Training on the Physical Performance of Patients With Chronic Schizophrenia With Sarcopenia.
- ClinicalTrials.gov ID
- NCT07183969
- Acronym / sponsor ID
- LEST-CSchizo / CShih
- Conditions
- Patients With Chronic Schizophrenia
- Keywords
- Lower extremity strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 19 Sep 2025 (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.
The increase in chronic schizophrenia patients with sarcopenia is currently an important healthcare issue in Taiwan and requires enhanced prevention and progress. Therefore, the purpose of this study was to understand the prevalence of sarcopenia in patients with chronic schizophrenia and to explore the effect of lower limb strength training on the physical functional performance of patients with chronic schizophrenia and sarcopenia. This study adopted a quasi-experimental design method, and the research process was divided into two stages. In the first stage, the SARC-CalF questionnaire was used to initially screen suspected chronic schizophrenia patients in a psychiatric hospital in central Taiwan. For sarcopenia cases, the skeletal muscle mass index (Skeletal Muscle Mass index) of suspected sarcopenia cases is further compared with the body composition analyzer (Inboby) to confirm the diagnosis of sarcopenia. Statistical analysis of the prevalence of sarcopenia in patients with chronic schizophrenia. In the second phase of the study, 4 chronic disease areas (two chronic disease areas for men and women) were randomly divided into experimental groups and control groups. The experimental group received a 16-week lower limb muscle strength training program, while the control group received routine care. The two groups conducted one pre-test and two post-tests, and the measurement content included physical function performance (Short Physical Performance Battery (SPPB), sarcopenia quality of life (SarQoL), and fall incidence). It is expected that the development of a set of non-pharmacological care measures will help patients in chronic psychiatric wards to become independent and slow down the progression of sarcopenia.
Detailed description
Methods:
The purpose of this study was to investigate the effects of lower extremity muscle training on the functional performance of sarcopenia in patients with chronic schizophrenia . The study will to examine the effectiveness of a 16-week lower extremity muscle training program on the functional performance of of sarcopenia in patients with chronic schizophrenia Sample size calculation. Sample size was calculated using G*Power 3.1.9.2 software, with reference to a randomized controlled study (Nygård et al., 2023) on the integration of plyometric training into the long-term collaborative care of people with psychosis. ANOVA: Repeated measures, between factors, Effect size: 0.5, α = 0.05, Power = 0.8, 2 groups, 3 measurements per group, results showed that at least 24 cases were enrolled in each group. However, in order to increase the statistical validity and to take into account the possibility of dropout or low attendance, the default attrition rate was 25%, with 30 cases in each group. Considering that the ratio of males to females with psychosis is 1.4:1, the sample size of this study is estimated to be 40 cases in each of the experimental and control groups (24 males and 16 females in each group), making a total of 80 subjects.
Data analysis:
In this study, the data were collected and compiled, coded and entered into a computer file, and processed using the SPSS for windows version 22.0 statistical package for statistical analysis, with the significant level set at α=0.05. The data were analyzed and analyzed using the SPSS for windows version 22.0 statistical software.
Steps Based on the screening results, eight chronic wards with a high number of myasthenia gravis chronic psychosis cases were selected and divided into two groups according to gender (24 males and 16 females in each group), which were randomly assigned to the experimental and control groups by drawing lots with an opaque envelope by a non-study project staff member (a nurse practitioner supervisor). After explaining the purpose of the study and the study process to the subjects, and after the subjects had agreed to participate in the study, they were asked to sign the consent form by telephone with their family members (note the date and time of the telephone call for family members' consent). After explaining the purpose of the study and the study process to the subjects, and after the subjects had agreed to participate in the study, they were asked to sign the consent form by telephone with their family members (note the date and time of the telephone call for family members' consent).
A total of three outcome measures were assessed at pre-intervention, 8 weeks post-intervention, and 16 weeks post-intervention. In order to avoid measurement bias, the measurements in each group were performed by the same tester (facilitator).
Total of 16 weeks of lower extremity strength training was implemented in the experimental group. The training content was designed with reference to the literature and in discussion with senior psychiatric nursing staff, an ageing physical fitness instructor, and the director of the rehabilitation department, and was attempted to be taught in the community to elderly people with sarcopenia and in a chronic psychiatric ward in central China, to confirm that it was feasible to implement and that it was expected to be effective. The total number of interventions in this study was 48 (3 per week, each lasting approximately 1 hour for 16 weeks). In the week prior to the study intervention, the same professional physical fitness instructor and facilitator came to the lobby of the experimental group ward to teach and instruct the subjects on the lower limb plyometric exercises 3 times a week for 1 hour, for a total of 3 sessions. 16 weeks of the lower limb plyometric interventions were conducted by the same professional physical fitness instructor for the female ward and by the same facilitator for the male ward.
In the experimental wards, lower extremity muscle training was performed once every 3 days per week at a time slot selected by the facilitator, who assessed with the ward nursing staff the appropriateness of the day's vital signs and physical condition for performing the lower extremity training. Because of the benefits of lower extremity strength training in preventing sarcopenia and falls, after the completion of this study, the control group will be provided with instruction and guidance on lower extremity strength training maneuvers, 3 times per week for 1 hour each time, for a total of 3 times, and will be encouraged to continue to perform the exercises in their daily lives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental groups | Experimental | Other: lower limb muscle strength training program16-week lower limb muscle strength training program |
| control groups | No intervention | –received routine care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) Suitable for participation in this study as assessed by the attending physician.
- (2) After explaining the purpose of the study and the study process, family members and study subjects were asked to agree to participate in the study and to complete the consent form for signature.
Key exclusion criteria (4 listed)
- (1) Those who are unable to walk unaided.
- (2) Severe structural disability that prevents the performance of lower extremity training.
- (3) Those with severe psychiatric symptoms that prevent them from concentrating and following instructions.
- (4)Participation in a lower extremity muscle training program or intervention within one year.
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 |
|---|---|---|
| lower limb muscle strength training programEach plyometric training session consists of warm-up stretching, lower limb plyometrics, and gentle stretching. Warm-up stretching, there are 6 movements, push the window, pull the rope, hands up, stretch from side to side, lift one foot and open and close both feet. Do 10 repetitions of each movement, 2 rounds, and keep breathing normally for a few repetitions. Lower Extremity Plyometrics: 3 rounds of 6 plyometrics with 1 minute of recovery time between each round. The six lower body plyometrics exercises are performed by gradually increasing the load in a manner that increases the number of seconds the exercise is held. Gentle Stretching: Continuous training of muscles makes them tense, stretching can lengthen muscle fibers, increase muscle elasticity, and improve blood circulation to eliminate post-training fatigue (H.K. Chen, 2022). Perform each gentle stretching movement left and right once, hold for 30 seconds each time, and keep breathing normally (no shutting up of breath). | Other | experimental groups |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: baseline、8weeks、16weeks
Chair Stand Test' Chair Stand Test、Balance tests、 Gait speed test
The Sarcopenia Quality of Life Questionnaire (SarQoL-TW)
Time frame: baseline、8weeks、16weeks
Chinese version of the Taiwan version
fall incidence
Time frame: baseline、8weeks、16weeks
medical records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. 無
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower limb muscle strength training program in people with Patients With Chronic Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 19 Sep 2025. 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 Taiwan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: baseline、8weeks、16weeks). The study lists 3 primary outcomes in all. 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 19 Sep 2025.