The Effect of Exercise Intervention on Posture, Trunk Flexibility and Spine Function in Patients With Parkinson's Disease

August 5, 2024 updated by: National Taiwan University Hospital

The primary goal of this clinical trail is to compare the effect of a five-week specific motor interventions on the postural alignment, trunk range of motion and spine function in patients with Parkinson's disease. The secondary goal is to investigate the effect of specific motor interventions on pain, balance, gait, and quality of life.

Participants will:

be randomly allocated to a control group or an exercise group and will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks. Each group will be assessed for posture, trunk range of motion, spine function, pain, balance, gait, and quality of life before and after the intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomly allocated to a control group or an exercise group and will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks. Each group will be assessed for posture, trunk range of motion, spine function, pain, balance, gait and quality of life before and after the intervention.

Posture evaluation was performed by measuring the angles of Flexion and Side-bending, by placing marks on the Spinal process of 7th cervical spine and the Spinal process of 5th lumbar spine, and by taking images of the Sagittal plane and Frontal plane. A digital flat-panel camera was used to take images in the sagittal plane and the coronal plane, and the angle between the line connecting the seventh cervical process of the spine and the fifth lumbar process of the lumbar spine and the vertical line was measured on the images; the angle in the coronal plane was defined as the anterior tilt angle, and that in the coronal plane was defined as the lateral bending angle.

Trunk flexion range of motion is measured using a goniometer and a tape measure in the following manner: Trunk flexion range of motion is measured with the trunk flexed anteriorly: the starting position of the case is standing in an upright position, and the tape measure is fixed to the seventh cervical vertebrae and the first vertebrae on the spinous processes, then the case is asked to relax the trunk forward to the end of the flexion without anteriorly tilting the pelvis. The difference between the tape measure in forward bending and upright position was taken as the value of trunk anterior tilt mobility. Trunk extension range of motion: The starting position of the case was standing in an upright position, and a tape measure was fixed on the spinous processes of the seventh cervical vertebrae and the first vertebrae of the recommended vertebrae. After the case was asked to relax the trunk with both hands and bend the trunk back to the bottom without tilting the pelvis posteriorly, and the difference between the posterior bending and the tape measure in the upright position was used as a value of the trunk extension range of motion. Trunk side-bending range of motion: The starting position of the case was standing upright, the center of the joint goniometer was aligned with the spinal process of the first segment of the recommended vertebrae of the case, one side of the goniometer was perpendicular to the floor, and the other side was aligned with the seventh segment of the cervical vertebrae of the case, the case was asked to make a left/right side-bending motion, and the angle between the left/right side-bending and the upright position was subtracted as the value of trunk side-bending range of motion. The angle between the left/right lateral bend and the upright position was subtracted to obtain the value of trunk lateral bending activity. Trunk rotation range of motion: With the case in a seated but not reclined position, the center of the joint goniometer was aligned with the center of the case's head, with one side of the goniometer parallel to the line of the iliac crest of the pelvis, and the other side parallel to the line of the shoulder crests on both sides. One side of the goniometer was parallel to the line of the iliac crest of the pelvis and the other side was parallel to the line of the shoulder crests on both sides of the body. The case was asked to perform a left/right rotation, and the angle between the left/right rotation and the seated position was subtracted to obtain a value for the degree of torso rotation.

Spinal function is assessed by evaluating the functional activities related to the spine, including Functional axial rotation and Supine to and from standing. The Functional Axial Rotation Test is performed by asking the patient to use a Cervical Range of Motion (CROM) device in a sitting position to measure the angle of rotation of the case when viewed from the left/right side. The lying to standing test is performed by asking the patient to use a Cervical Range of Motion (CROM) device to measure the angle of rotation of the case when viewed from the right/left side. The Lying to Standing Test measures the time taken by the case to move from standing to lying and lying to standing.

Pain was assessed using the Visual Analogue Scale , VAS, which asks the patient about the degree of low back pain.

The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST) is used to evaluate balance in cases of balance impairment (e.g., Parkinson's disease, brain injury, vestibular disorders, stroke, or multiple sclerosis). The assessment consists of four sub-balance systems with 14 items each scored 0, 1, or 2 depending on performance, ranging from 0 to 28, with higher scores indicating better balance. The four sub-balance systems included in the test are Anticipatory postural adjustments, Reactive postural control, Sensory orientation and Dynamic gait.

Walking speed was assessed using the 10 m walk test, which involves walking a distance of 14 meters at a comfortable speed and recording the time taken from the second to the twelfth meter in order to calculate the walking speed of the case, with the use of a walking aid if necessary.

The gait assessment will record the parameters of walking and assess them using the Tinetti Mobility Test (TMT). The TMT is used to assess the gait performance of elderly people, people with Parkinson's disease, brain injury, stroke or multiple sclerosis. The assessment is performed by asking the patient to walk a distance of 25 feet in a straight line at a comfortable speed. The administrator can either directly observe or video-record the gait of the patient, or use a walking aid if necessary. The assessment includes the observation of hesitancy to start walking, height of the raised foot, gait length, gait symmetry, continuity of stride, walking path, trunk stability, and width of stride, with a score of 0, 1, or 2 for each item. Each item was scored as 0, 1 or 2, ranging from 0 to 12, with higher scores indicating a more problem-free gait.

Quality of life is assessed using the short version of the Parkinson's Disease Questionnaire (PDQ-8). The PDQ8 is a self-completion questionnaire with eight questions covering eight domains, including activities of daily living, exercise, cognition, social support, communication, emotional well-being, shame, and feelings of physical discomfort, with the lower the score, the better the quality of life and health.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Recruiting
        • National Taiwan University Hospital HsinChu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hoehn-Yahr classification 2 to 3
  • Regular compliance with medication program
  • Stable medical condition and vital signs, conscious
  • Be able to follow instructions.

Exclusion Criteria:

  • Cognitive impairment or dementia who are unable to cooperate with therapy or functional assessment
  • Patients with musculoskeletal injuries or surgeries that have resulted in limited mobility
  • Patients with physician-diagnosed cardiorespiratory disorders with activity limitations
  • Patients with acute neurological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise
Exercise group will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks
Other: exercise
50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks
Other: education
The patient will be given a one-time exercise education session and a 50-minute video that included stretching, core exercises, gross motor movements and balance exercises that could be practiced at home.
Other: education
The patient will be given a one-time exercise education session and a 50-minute video that included stretching, core exercises, gross motor movements and balance exercises that could be practiced at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postural alignment of frontal and sagittal plance
Time Frame: before and immediately after the intervention
The angles of Flexion and Side-bending of the trunk in degrees
before and immediately after the intervention
range of motion of trunk flexion and side-bending
Time Frame: before and immediately after the intervention
The range of motion of trunk flexion and side-bending will be evaluated in degrees
before and immediately after the intervention
Supine to and from sitting
Time Frame: before and immediately after the intervention
The time of supine to and from sitting is measured in seconds
before and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale of low back pain
Time Frame: before and immediately after the intervention
It is a scale from 0 to 10. The higher score means the patient has more severe pain.
before and immediately after the intervention
The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST)
Time Frame: before and immediately after the intervention
It is a scale from 0 to 28. The higher score means the patient has no impairment in their balance.
before and immediately after the intervention
10 meter gait speed
Time Frame: before and immediately after the intervention
the speed of gait is measured in meters per second
before and immediately after the intervention
Tinetti Mobility Test (TMT)
Time Frame: before and immediately after the intervention
It is a scale from 0 to 12. The higher score means the patient has a better gait pattern.
before and immediately after the intervention
the short version of the Parkinson's Disease Questionnaire (PDQ-8)
Time Frame: before and immediately after the intervention
quality of life will be measured by the PDQ-8. It is a scale from 0-32. The higher scale means the patient has worse quality of life.
before and immediately after the intervention
Falls Efficacy Scale International (FES-I)
Time Frame: before and immediately after the intervention
It is a scale from 16 to 64. The higher score means the patient is more afraid of falling down.
before and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202307076RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe