NCT07183969

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 16, 2024

Last Update Submit

September 13, 2025

Conditions

Keywords

Lower extremity strength training

Outcome Measures

Primary Outcomes (3)

  • Short Physical Performance Battery (SPPB)

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

    baseline、8weeks、16weeks

  • The Sarcopenia Quality of Life Questionnaire (SarQoL-TW)

    Chinese version of the Taiwan version

    baseline、8weeks、16weeks

  • fall incidence

    medical records

    baseline、8weeks、16weeks

Study Arms (2)

experimental groups

EXPERIMENTAL

16-week lower limb muscle strength training program

Other: lower limb muscle strength training program

control groups

NO INTERVENTION

received routine care

Interventions

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).

experimental groups

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsaotun Psychiatric Center,MOHW

Tsaotun, Nanton, 542, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. candidate

Study Record Dates

First Submitted

July 16, 2024

First Posted

September 19, 2025

Study Start

September 20, 2024

Primary Completion

January 16, 2025

Study Completion

January 26, 2025

Last Updated

September 19, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations