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Parkinson DiseaseNCT04810897

Effects of Home-based Exercise in Parkinson's Disease

An observational study of Parkinson Disease, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Home-based exercise program focusing on axial rigidity could be used as an adjunct rehabilitation program to improve rotational movement, gait and functional movement associated with axial rigidity in individuals with PD. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
Exercise
How many people
20 participants
Where
1 siteThailand
Study dates
1 Jul 2020to 30 Nov 2021
Phase
Observational
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 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Individuals with Parkinson's disease (PD) who refers from a public hospital and recruits from community.

  1. Inclusion Criteria;
  • Clinically diagnosed with PD stages 1.5 to 3 as assessed by the modified Hoehn and Yahr scale
  • The age groups between 50 and 75 years
  • Taking PD medication regularly for at least a month
  • No signs of wearing-off phenomenon
  • Able to walk independently without any assistive device and 6) able to follow commands and instructions
  1. Exclusion Criteria;
  • Clinically diagnosed with dementia or other neurological or cardiopulmonary diseases
  • Musculoskeletal problems that could influence the test performance such as arthritis or severe leg pain
  • High blood pressure (more than 140/90 mmHg)
  • Haemodialysis
  • Visual problems that could not be adjusted with lenses or glasses
  • Taking medicine which affected to functional movement.

Trial locations and contacts

1 site in 1 country.

Fuengfa Khobkhun, PhD contact

+66953539196

fuengfa.kho@mahidol.edu

Thailand1 site, 1 recruiting

  • Fuengfa Khobkhun

    Nakhon Pathom, 73170

    Fuengfa Khobkhun, PhD, +66953539196, fuengfa.kho@mahidol.edu

    Fuengfa Khobkhun, PhD

    Recruiting

Other trials in Thailand

About this study

Official title: Effects of Home-based Exercise Programme in Individuals With Parkinson's Disease

Home-based exercise program focusing on axial rigidity could be used as an adjunct rehabilitation program to improve rotational movement, gait and functional movement associated with axial rigidity in individuals with PD.

Read the detailed description

Typically, individuals with PD revert to more primitive movement patterns, which lack many of the automatic postural adjustments and axial movements that accompany simple activities, such as supine to standing, getting up from sitting or turning over in bed. The present study is designed to allow patients and their relatives to perform exercises by themselves conveniently at home. The results were considered a vital component of a complex intervention and were played an integral part in the implementation process of exercises in functional performance. Furthermore, this study will prove sufficient high-quality evidence to investigate whether improvements in function due to exercise-based rehabilitation are associated with reducing axial rigidity in individuals with PD.

Currently, there is a lack of evidence for the effectiveness of home-based exercise programs in PD patients in Thailand. For the present study, we devised a home-based 10-week exercise program focusing on segmental rotation and task-specific movements for turning practice to determine effects on axial mobility and turning. The aimed of this study to examine the effects of a 10-week task specific home-based exercise program on turning kinematics, gait and stepping characteristics, the Functional Reach test (FRT), the Unified Parkinson's Disease Rating Scale (UPDRS), the Freezing of Gait questionnaire (FOG) and the Fall Efficacy Scale International (FES-I) in individuals with PD.

Being tested
Exercise
Keywords
Exercise, Gait characteristics
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Exercise programme is reported in the clinical trial registration number is NCT03473834.

Study groups in NCT04810897
Study groupRoleWhat they receive
Parkinson's diseaseThe neurologists will inform the individuals with PD that we are doing this research and we will attach the research advertisement at Movement Disorder Clinic, Division of Neurology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand. Only individuals with PD who meet the inclusion and exclusion criteria will be invited to participate in the study. The researcher will inform participants about the purpose, procedure, and advantage of the study prior to participation in the study. Individuals with PD will be asked to sign an informed consent if they agree to participate in the study.
Receives: Other: Exercise

What is being measured

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

  1. The Unified Parkinson's Disease Rating Scale (UPDRS),

    The UPDRS consists of four major parts: 1) mental, behavior and mood, 2) activities of daily living, 3) motor examination and 4) complications of therapy, in totally 42 items. Each item has multiple points that include zero for normal or no problems, 1 for minimal problems, 2 for mild problems, 3 for moderate problems and 4 for severe problems. The higher score would indicate the more severe problems in individuals with PD.

    Measured: 3 months

  2. Functional axial rotation - physical (FAR)

    A clinical measurement for axial mobility, which is usually used to measure spinal flexibility. If the FAR yields a high score, it implies better flexibility, axial movement and postural control and balance.

    Measured: 3 months

  3. Gait and turning characteristics

    Gait will be measure by the participants will stand at the edge of the platform (The Zebris FDM-System-Gait Analysis; Zebris Medical GmbH, Isny, Germany) and will be asked to walk barefoot at a comfortable speed to the other end of the platform, this will be repeated for a total of 3 trials. The averaged data including foot rotation (deg), step width (cm), step length (cm), step time (sec), cadence (steps/min) and gait velocity (km/s) were analysed and used in the comparisons. Turning kinematics (the onset latencies of body segments reorientation and stepping characteristics) will be recorded during participants performed a turning on level ground at 180° in standing position by using the Inertial Measurement Unit (xIMU) (x-IMU, x-io Technologies Ltd., UK).

    Measured: 3 months

Secondary outcomes (3)

  1. Time Up and Go

    The average of 3 attempts of the time required to rise from a chair, walk 3 m, return to the chair, and sit down again will be collected. The faster times indicate better balance and mobility.

    Measured: 3 months

  2. 10 Meter walk test

    Participants will be instructed to walk at a comfortable pace following a 10-meter distance marked on the floor. The time of 10 Meter walk test will be calculated

    Measured: 3 months

  3. Global rating scale (GROC)

    A GROC score of zero will be considered as unchanged, and GROC scores of +1, +2, +3, +4 and +5 represent an increase in perceived improvement. In contrast, GROC scores of -1, -2, -3, -4, and -5 indicate the degree of perceived deterioration.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start1 Jul 2020
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04810897
Sponsor's protocol ID
MU-CIRB 2020/048.1902
Status last verified
Mar 2021
First submitted
16 Mar 2021
Last updated
23 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data from the patients so, it could be privacy to ask for IPD data.

Publications

  • Khobkhun F, Srivanitchapoom P, Thanakamchokchai J, Richards J. The effect of a home-based exercise program on gait characteristics in an individual with Parkinson's disease over a one-year period: A case study. J Bodyw Mov Ther. 2024 Jul;39:512-517. doi: 10.1016/j.jbmt.2024.03.039. Epub 2024 Mar 19.

    PubMed 38876677

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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 Thailand. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fuengfa Khobkhun, PhD (+66953539196, fuengfa.kho@mahidol.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Unified Parkinson's Disease Rating Scale (UPDRS), (time frame: 3 months). 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?

On the ClinicalTrials.gov record for NCT04810897, which also lists 1 linked publication.

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 23 Mar 2021.

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