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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Taiwan1 site
  • Tsaotun Psychiatric Center,MOHW

    Tsaotun, Nanton, 542

Other trials in Taiwan

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.

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 groups in NCT07183969
Study groupRoleWhat they receive
experimental groupsExperimental16-week lower limb muscle strength training program
Receives: Other: lower limb muscle strength training program
control groupsNo interventionreceived routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Physical Performance Battery (SPPB)

    Chair Stand Test' Chair Stand Test、Balance tests、 Gait speed test

    Measured: baseline、8weeks、16weeks

  2. The Sarcopenia Quality of Life Questionnaire (SarQoL-TW)

    Chinese version of the Taiwan version

    Measured: baseline、8weeks、16weeks

  3. 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.

  1. First posted19 Sep 2025
  2. Study start20 Sep 2024
  3. Primary completion16 Jan 2025
  4. Study completion26 Jan 2025

Resources

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)
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

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.

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