Combined Exercise and PMS: Impact on Biopsychosocial Function in Older Adults With Schizophrenia

NCT07194460 | Not Yet Recruiting

• 2 other identifiers: YJYZD202406202503650102197808083517
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project consists of two randomized parallel - group experiments targeting older adults with schizophrenia, aiming to evaluate the therapeutic effect of Peripheral Magnetic Stimulation (PMS). Experiment 1 (Efficacy of PMS): During a 4 - week intervention period, participants are randomly assigned to receive active PMS or sham PMS. The primary objective is to determine whether PMS can reduce the clinical symptom burden and improve biopsychosocial functioning compared with sham stimulation through electroencephalogram (EEG) signal acquisition and evaluation. Secondary objectives include the effects on cognition, mood, sleep, and health - related quality of life, as well as safety and tolerability (adverse events monitoring). Experiment 2 (Comparison of Intervention Effects): The subjects are randomly divided into three groups: exercise combined with PMS group, PMS alone group, and exercise alone group. Each group is arranged by relevant professionals to carry out the corresponding intervention for 4 weeks. The main purpose is to examine the differences in the effects of the three intervention methods (exercise combined with PMS, PMS alone, and exercise alone) in improving patients' conditions, including the impact on exercise - related physical performance, functional mobility, etc. Secondary objectives include the impact on overall function and quality of life, along with safety monitoring. In both experiments, outcome indicators are measured from baseline to post - intervention (and, where feasible, short - term follow - up) by assessors who are blinded to group allocation using appropriate tools. It is hypothesized that in Experiment 1, PMS will be superior to sham stimulation; in Experiment 2, the effect of exercise combined with PMS in improving patients' motor and related functions will be better than that of PMS alone or exercise alone, which supports PMS as a scalable auxiliary means for the rehabilitation of this population.

Conditions

Schizophrenia Patients

Outcome Measures

Primary Outcomes (3)

• Positive and Negative Syndrome Scale (PANSS) score

  Positive and Negative Syndrome Scale (PANSS) Score Description: A 30-item scale assessing positive symptoms, negative symptoms, and general symptoms. Unit of Measure: Score (range 30-210)

  After baseline assessment, participants will undergo either Peripheral Magnetic Stimulation (PMS) or exercise intervention, followed by follow-up assessments at Week 4 and Week 8.

• resting-state electroencephalography (resting-state EEG)

  Resting-State Electroencephalography (EEG) Description: EEG data collection and analysis, including 5-band power (δ, θ, α, β, γ) and brain connectivity. Unit of Measure: Microvolts squared per Hertz (μV²/Hz) for power bands, correlation coefficient for brain connectivity.

  Assessed at baseline (pre-intervention) and immediately post-intervention (within 30 minutes of the final session).

• 6-minute walk test

  6-Minute Walk Test (6MWT) Description: A standardized test measuring the distance walked in 6 minutes. Unit of Measure: Distance (meters)

  After baseline assessment, participants will undergo either Peripheral Magnetic Stimulation (PMS) or exercise intervention, followed by follow-up assessments at Week 4 and Week8 .

Secondary Outcomes (2)

• muscle mass index

  Assessed at baseline (pre-intervention), at Week 4 follow-up, and at Week 8 follow-up

• Sit-to-Stand Test

  Assessed at baseline (pre-intervention), at Week 4 follow-up, and at Week 8 follow-up

Study Arms (5)

Peripheral Magnetic Stimulation (PMS) treatment group

EXPERIMENTAL

Treatment will be administered using a Peripheral Magnetic Stimulation (PMS) device. The intervention involves directing magnetic fields to stimulate specific peripheral nerve regions to regulate neural activity and improve symptoms.

Device: Peripheral Magnetic Stimulation (PMS)

Sham control group

SHAM COMPARATOR

The placebo group will undergo a treatment process similar to the PMS intervention group, but without actual peripheral magnetic stimulation. The intervention will simulate the PMS treatment process, using a sham device that resembles the PMS device in appearance, but without generating any magnetic or electric field stimulation.

Device: ham control group receiving PMS intervention

Exercise

EXPERIMENTAL

This exercise prescription includes four phases. First, a 5-minute warm-up (no sandbags/resistance bands) with walking in place, ankle rotations, and shoulder movements to boost blood flow and prevent injuries. Next, 10-12 minutes of leg strength training: sandbags for half squats (strengthen thighs, hips, knees), calf raises (enhance calf strength and lower limb stability), and resistance bands for standing leg abductions (improve hip/outer thigh strength/coordination). Then, 8-10 minutes of neurocoordination training with sandbags/resistance bands: marching in place (better leg coordination/endurance), gait training (improve balance/neural coordination), and step turns (increase gait flexibility/body control). Finally, a 5-minute relaxation with leg/ankle stretches to reduce post-exercise soreness.

Other: Exercise

PMS＋Exercise

EXPERIMENTAL

Following the completion of PMS, exercise training is randomly conducted.

Other: PMS＋Exercise

PMS

EXPERIMENTAL

This PMS refers to the peripheral magnetic stimulation administered in Experiment 2, serving to distinguish it from that in Experiment 1.

Device: Peripheral Magnetic Stimulation (PMS)

Interventions

Peripheral Magnetic Stimulation (PMS) DEVICE

Treatment will be administered using a Peripheral Magnetic Stimulation (PMS) device. The intervention involves directing magnetic fields to stimulate specific peripheral nerve regions to regulate neural activity and improve symptoms.

PMS; Peripheral Magnetic Stimulation (PMS) treatment group

ham control group receiving PMS intervention DEVICE

Identical to the experimental group in all procedures, except that no electrical stimulation is delivered.

Sham control group

Exercise OTHER

See previous sections

Exercise

PMS＋Exercise OTHER

See previous sections

PMS＋Exercise

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be aged ≥60 years.
• Diagnosis of schizophrenia based on the International Classification of Diseases - 10th Edition (ICD-10) or Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5).
• Diagnosis must be made for ≥6 months, with clinical manifestations of schizophrenia (e.g., hallucinations, delusions, thought disorder, etc.).
• No history of severe acute psychiatric episodes or hospitalizations within the last 3 months prior to enrollment.
• Symptoms must be controllable, with no reliance on acute psychiatric intervention.
• Participants must be able to understand the study's purpose and procedures and provide written informed consent. If the participant is unable to provide full informed consent (e.g., due to severe cognitive impairment), informed consent must be obtained from a legal guardian.

You may not qualify if:

• Schizoaffective disorder or bipolar disorder with psychosis.
• Elderly individuals with multiple chronic diseases but who still maintain good functional status and quality of life.
• Presence of severe cardiovascular diseases, liver or kidney dysfunction, cerebrovascular diseases, or other physical conditions that may affect treatment.
• Patients with contraindications to peripheral magnetic stimulation (PMS) treatment or EEG.

Sponsors & Collaborators

• Yuntong Zhang: lead

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a triple-blind design. Patients, researchers, and data analysts are all blinded to the group assignments (treatment or control group) throughout the study. The randomization process is managed by an independent third party, and outcome data analysis is conducted by researchers who are unaware of group allocations. This ensures the minimization of bias during the trial and data interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Student, School of Rehabilitation, Shanghai University of Medicine & Health Sciences

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 26, 2025
• Study Start: September 28, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 5, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: after the article is published