Effects of Home-based Exercise in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04810897
• Other study ID #: MU-CIRB 2020/048.1902
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2021
• Source: Mahidol University
• Contact: Fuengfa Khobkhun, PhD
• Phone: +66953539196
• Email: fuengfa.kho[@]mahidol.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

2. 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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Thailand	Fuengfa Khobkhun	Nakhon Pathom

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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).	3 months
Secondary	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.	3 months
Secondary	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	3 months
Secondary	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.	3 months