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Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease

Primary Purpose

Parkinson Disease, Exercise, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Balance
Endurance
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Neurodegenerative disorders, physical activity, balance, endurance

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Parkinson Disease, Hoehn & Yahr score of 1-3.

Exclusion Criteria:

  • History or evidence of dementia or other neurological impairment/cardiovascular diseases that may affect the high-intensity endurance workout

Sites / Locations

  • Universidad de Vigo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

The experimental group (EG) participated in a once a week physical exercise program for 8 weeks. The session consisted of balance training, followed by aerobic endurance training with exercise peddlers. At the beginning of the program, each session lasted 25 minutes and progressed to 35 minutes, in the last two weeks

The control group (CG) only performed routine balance exercises once a week (10 min)

Outcomes

Primary Outcome Measures

Sintomatology of Parkinson Disease
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates the degree of symptomatology of the person with Parkinson's Disease. The total score range ranges from 0 to 200, with higher values indicating a greater impact of the symptoms. Each item is scored from 0 to 4, with 0 being the least and 4 the most severe. The scores are added.
Quality of life in Parkinson Disease: PDQ39
The quality of life questionnaire for Parkinson's disease is a specific questionnaire that evaluates the quality of life, where a lower score means that the patient has a better quality of life. It consists of 39 questions, and its value is expressed in percentages, the percentages closest to zero express a better quality of life. In addition, their results can also be expressed in 8 different areas (mobility, activities of daily life, stigma, emotional well-being, social support, communication, body discomfort, cognitive impairment), which are interpreted in the same way.
Physical Conditions
The Senior Fitness Test, is a battery of 7 tests to evaluate the physical state of the elderly, and has been validated for people with Parkinson's Disease. This battery evaluates the strength of lower and upper limbs with the 30 seconds chair stand and arm curl tests, to more repetitions, more strength. It also evaluates the flexibility of both lower and upper limbs with the chair sit and reach and back stractch tests, which are measured in centimeters, to more centimeters greater flexibility. Aerobic endurance is assessed by means of the 6 minute walk test that is measured in meters, and the 2 minute step test that is measured in cycles. The more number of cycles and meters, the better aerobic resistance. The balance is evaluated by means of the 8 foot up and go test, which is measured in seconds, and the less the better the balance. These results by means of a mathematical formula give an absolute value that to higher score better physical condition
Balance
Tinetti test The objective of the Tinetti test is to evaluate the possible alterations of balance in a population of elderly people. The test consists of two parts: nine elements of balance and six elements of march. The maximum total score is 28, and would mean that gait and balance are normal

Secondary Outcome Measures

Full Information

First Posted
March 11, 2019
Last Updated
March 19, 2019
Sponsor
University of Vigo
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1. Study Identification

Unique Protocol Identification Number
NCT03882398
Brief Title
Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease
Official Title
Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease Population: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
TITLE: Effects of a high-intensity progressive-cycle program on quality of life and motor symptomatology in Parkinson's disease population BACKGROUND: The benefits of aerobic exercise in persons with Parkinson's disease (PD) have been widely studied; however, little research has been done on the effect of high-intensity aerobic exercise in this group. HYPOTHESIS: The high-intensity aerobic training in pedaliers, combined with balance training, improves motor symptoms and quality of life in a population with Parkinson Disease, Hoehn & Yahr 1-3. OBJETIVES: To ascertain whether high-intensity aerobic training with exercise peddlers and balance training can improve motor symptoms and quality of life in a PD population of Hoehn &Yahr (H&Y) disability score 1-3. METHODOLOGY Setting: Rehabilitation centers in secondary care. Design: A pilot randomized controlled trial. Participants: A total of 14 patients participated in the 8-week study. Interventions: They were comprised of a control group (n=7) that followed a balance protocol and an experimental group (n=7) that performed high intensity (70%) aerobic workout using an exercise peddler + a balance protocol once a week. Main Outcome Measures: The primary outcome measures included the 8-Foot Up and Go, test, 6-minute walk test, test 2-minute step tets, Parkinson Disease Questionnaire-39 (PDQ39), Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Tinetti test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Exercise, Physical Activity, Quality of Life
Keywords
Neurodegenerative disorders, physical activity, balance, endurance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pilot randomized controlled trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Fourteen patients were randomly assigned to the two groups
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group (EG) participated in a once a week physical exercise program for 8 weeks. The session consisted of balance training, followed by aerobic endurance training with exercise peddlers. At the beginning of the program, each session lasted 25 minutes and progressed to 35 minutes, in the last two weeks
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group (CG) only performed routine balance exercises once a week (10 min)
Intervention Type
Other
Intervention Name(s)
Balance
Intervention Description
Balance program (10 minutes) Balance on bosu ball and ball drills Coordination in rings with single leg stance and ball drills Straight line walk with head up Straight line walk and hip flexion, knee flexion and head up (Duration: 10 minutes. Sets: 2 minutes per exercise. Rest: 30 seconds between exercises)
Intervention Type
Other
Intervention Name(s)
Endurance
Intervention Description
Progressive-cycle program (15-25 minutes) Warming up Pedalling with 0 resistance (2 minutes) Main Part* Week 1-2 : 3x2 minutes Week 3-4 : 4x2 minutes Week 5-6 : 5x2 minutes Week 7-8 : 6x2 minutes Return to resting stage Pedalling with 0 resistance (1 minute) (*Pedalling with resistance set at 3-4. Rest: 2 minutes between sets or 120 beats/minute. One more set added every two weeks and workout intensity maintained at 70% of heart rate reserve-HRR)
Primary Outcome Measure Information:
Title
Sintomatology of Parkinson Disease
Description
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates the degree of symptomatology of the person with Parkinson's Disease. The total score range ranges from 0 to 200, with higher values indicating a greater impact of the symptoms. Each item is scored from 0 to 4, with 0 being the least and 4 the most severe. The scores are added.
Time Frame
12 weeks
Title
Quality of life in Parkinson Disease: PDQ39
Description
The quality of life questionnaire for Parkinson's disease is a specific questionnaire that evaluates the quality of life, where a lower score means that the patient has a better quality of life. It consists of 39 questions, and its value is expressed in percentages, the percentages closest to zero express a better quality of life. In addition, their results can also be expressed in 8 different areas (mobility, activities of daily life, stigma, emotional well-being, social support, communication, body discomfort, cognitive impairment), which are interpreted in the same way.
Time Frame
12 weeks
Title
Physical Conditions
Description
The Senior Fitness Test, is a battery of 7 tests to evaluate the physical state of the elderly, and has been validated for people with Parkinson's Disease. This battery evaluates the strength of lower and upper limbs with the 30 seconds chair stand and arm curl tests, to more repetitions, more strength. It also evaluates the flexibility of both lower and upper limbs with the chair sit and reach and back stractch tests, which are measured in centimeters, to more centimeters greater flexibility. Aerobic endurance is assessed by means of the 6 minute walk test that is measured in meters, and the 2 minute step test that is measured in cycles. The more number of cycles and meters, the better aerobic resistance. The balance is evaluated by means of the 8 foot up and go test, which is measured in seconds, and the less the better the balance. These results by means of a mathematical formula give an absolute value that to higher score better physical condition
Time Frame
12 weeks
Title
Balance
Description
Tinetti test The objective of the Tinetti test is to evaluate the possible alterations of balance in a population of elderly people. The test consists of two parts: nine elements of balance and six elements of march. The maximum total score is 28, and would mean that gait and balance are normal
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Parkinson Disease, Hoehn & Yahr score of 1-3. Exclusion Criteria: History or evidence of dementia or other neurological impairment/cardiovascular diseases that may affect the high-intensity endurance workout
Facility Information:
Facility Name
Universidad de Vigo
City
Pontevedra
ZIP/Postal Code
36005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease

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