ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000992404

Ethics application status

Approved

Date submitted

10/01/2025

Date registered

8/09/2025

Date last updated

8/09/2025

Date data sharing statement initially provided

8/09/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Morphofunctional Parameters and Quality of Life of People with Schizophrenia Practicing Nordic Walking

Scientific title

Specially Designed Exercises Utilizing Nordic Walking and Their Impact on Morphofunctional Parameters, Physical Activity Levels, and Quality of Life in Individuals with Schizophrenia: A Novel Approach to Physical Activation

Secondary ID [1]

State Fund For Rehabilitation of Disabled People (PFRON) - contract number: DEA/0000070/BF/D

Universal Trial Number (UTN)

U1111-1313-8615

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Schizophrenia

Physical Activity

Body Composition

Cardiometabolic diseases

Postural abnormalities

Pain

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

Other mental health disorders

Musculoskeletal

Other muscular and skeletal disorders

Cardiovascular

Hypertension

Diet and Nutrition

Obesity

Metabolic and Endocrine

Metabolic disorders

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Description of intervention:

The intervention consists of an 8-week Nordic Walking program for adults with schizophrenia, with three supervised sessions per week lasting 60–90 minutes each.

Materials provided: Nordic walking poles and Garmin Vivofit 4 smartbands to monitor step count and heart rate.
Session structure: Two sessions per week focus on Nordic Walking technique, and one session on resistance and strengthening exercises. All sessions are held outdoors in a green environment.
Procedures: The first six sessions teach proper Nordic Walking technique; the remaining eighteen sessions aim to refine technique, improve aerobic endurance, and strengthen muscles. Each session includes warm-up, main exercises, and cool-down, adapted individually based on participants’ physical and mental state.

Workout examples:

1. Half-Squat with Calf Raise
-Stand in a straddle stance with feet firmly on the ground.
-Bend your knees into a half-squat.
-Rise up onto your toes, then lower back down.

2.Arm Abduction with Resistance Band
-Stand in a straddle stance with arms extended forward.
-Place a resistance band around your wrists.
-Move your arms outward to stretch the band, then return to the starting position.

3.Arm Raise with Resistance Band
-Stand in a straddle stance with arms extended forward.
-Keep the resistance band stretched around your wrists.
-Raise your arms upward above your head, then lower them down while maintaining band tension.

4.Lateral Steps with Resistance Band
-Stand in a straddle stance with hands on your hips.
-Place a resistance band just above your ankles.
-Step to the side, abducting one leg while stretching the band (walk in a half-squat position).

5.Trunk Twists with Sticks
-Stand in a straddle stance holding sticks in front of your body.
-Rotate your torso to one side, then return to the center.
-Repeat on the opposite side.

6.Lunge with Arm Raise
-Step forward into a lunge with one leg.
-Keep your arms down at your sides.
-Raise your arms upward, then lower them back down while holding the lunge position.

Personnel: Sessions are led by a qualified and certified trainer responsible for both Nordic Walking and resistance exercises.
Group size: Sessions are conducted in groups of up to 12 participants.
Adherence monitoring: Attendance is recorded via checklists. Exertion levels are assessed with the Borg Rating of Perceived Exertion scale after each session. Smartband data on steps and heart rate are also monitored.
Personalization: Training intensity and difficulty are adjusted weekly based on participant feedback, Borg scale scores, smartband data, and trainer observations.
Organization: Sessions use varied group setups, including frontal and paired formations, to facilitate individualization and effective instruction.

Intervention code [1]

Lifestyle

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Body posture

Timepoint [1]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Primary outcome [2]

Posturography

Timepoint [2]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Primary outcome [3]

Quality of life

Timepoint [3]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Secondary outcome [1]

Physical activity level

Timepoint [1]

During the 8 weeks of intervention (on training days: immediately after training and after a full day before going to bed; on non-training days: after a full day before going to bed )

Secondary outcome [2]

Eating habits

Timepoint [2]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Secondary outcome [3]

Intensity of activity

Timepoint [3]

During the 8 weeks of intervention (immediately after training)

Secondary outcome [4]

Mental feeling

Timepoint [4]

During the 8 weeks of intervention (on training days: immediately after training and after a full day before going to bed; on non-training days: after a full day before going to bed)

Secondary outcome [5]

Musculoskeletal Pain

Timepoint [5]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Secondary outcome [6]

Antero-posterior curvature of the spine

Timepoint [6]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Secondary outcome [7]

Body height

Timepoint [7]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Secondary outcome [8]

Circumferences

Timepoint [8]

Prior to intervention (baseline values) and after the completion of the 8-week intervention

Eligibility

Key inclusion criteria

- Diagnosed schizophrenia
- A patient diagnosed with schizophrenia, without contraindications to physical activity, and qualified for the intervention by a physician
- Age between 18 - 60
- Informed consent from the participant to participate in the project

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Injuries to the musculoskeletal system acquired within two weeks prior to the start of the intervention
- Pregnancy
- Implanted pacemaker

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The variability of parameters before and after the intervention will be assessed by Wilcoxon test.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

3/09/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

State Fund For Rehabilitation Of Disabled People (PFRON) - contract number: DEA/0000070/BF/D

Address [1]

Country [1]

Poland

Primary sponsor type

University

Name

The Jerzy Kukuczka Academy of Physical Education

Address

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Research Ethics Committee from The Jerzy Kukuczka Academy of Physical Education in Katowice

Ethics committee address [1]

Mikolowska 72, 40-065 Katowice

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

09/05/2024

Ethics approval number [1]

4-V/2024

Summary

Brief summary

Schizophrenia, regarded as a civilization disease, often requires pharmacotherapy, which can lead to obesity and hypertension. Research suggests that physical activity can be an important support in therapy.  The aim of this study is to examine the impact of a Nordic Walking program on morphofunctional parameters and the quality of life of adults diagnosed with schizophrenia. The operational goal of the project is to create a Nordic Walking program tailored for individuals with schizophrenia, which will be based on scientific evidence and can be implemented in therapeutic practice.

Trial website

https://awf.katowice.pl/projekty-wspolfinansowane-pl/projekty-wspolfinansowane-przez-pfron

Trial related presentations / publications

Public notes

Research Group - Team for Physical Activity for Health (ZB2), Institute of Sports Sciences, Academy of Physical Education in Katowice

Contacts

Principal investigator

Name

Prof Anna Zwierzchowska

Address

Institute of Sports Sciences, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland

Country

Poland

Phone

+48 32 207 5133

Fax

[email protected]

Contact person for public queries

Name

Aleksandra Bula, PhD

Address

Institute of Sports Sciences, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland

Country

Poland

Phone

+48 79 566 3383

Fax

[email protected]

Contact person for scientific queries

Name

Anna Zwierzchowska

Address

Institute of Sports Sciences, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland

Country

Poland

Phone

+48 32 207 5133

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Data anonymization

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					Registered Ethics Committee.pdf
Other				Author's nutritional questionnaire	Author's nutritional questionnaire.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically