Multimodal Exercise Program on Parkinson's Disease Patients With Depression
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise group
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's Disease, A Multimodal Exercise Program, Aerobic Exercise, Depression, Health Related Quality of Life
Eligibility Criteria
Inclusion Criteria:
- be diagnosed PD in Hoehn and Yahr stage I-II22
- under stable medication treatment at least 3 months
- no disease limiting the patient's ability to perform the exercises
Exclusion Criteria:
- severe cardiovascular disorders
- neuromusculoskeletal disorder
- cognitive impairment
- recent participation in any physiotherapy or rehabilitation program
- have exercise regularly
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
exercise group
Arm Description
Control group maintained their regular lifestyle and received the routine care
Participants in the exercise group (EG) were instructed to engage performed exercise at least 3 times per week (30-50 minutes) or 10-15 minutes per section every day to accumulate 150 minutes per week for 8 weeks using disc (DVD) at home. Main exercise was moderate intensity aerobic exercise, an intensity of 55-70% of the heart rate reserve (HR max).
Outcomes
Primary Outcome Measures
GDS-15
consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986). Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.
PDQ-8
A sub-set of items is then selected from the PDQ-39 to create a shorter form version, the PDQ-8 (Jenkinson, Fitzpatrick & Peto, 1997). The sum of the scores can provide a single figure used to assess the overall health-related quality of life profile of the individual questioned. . Scores for each dimension range from 0 to 100, PDQ-8SI scores can be standardized on a scale from 0 to 100, with lower scores indicating better HRQoL.
Secondary Outcome Measures
UPDRS part II (ADL)
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987). The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. A total of 199 points are possible (199 represents the worst disability and 0 no disability). Part II: self-evaluation of the activities of daily life (ADLs). The scales part 2: motor experiences of daily living (13 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
UPDRS part III (motor ability)
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987). The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. Its 42 items are evaluated by interview and clinical observation. The motor section in particular to follow the progression of a person's Parkinson's disease. A total of 199 points are possible (199 represents the worst disability and 0 no disability). The scales part 3: motor examination (18 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Fatigue (FSS)
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989). The subject is asked to read each statement and circle a number from 1 to 7, the items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.
Sleep quality (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality.
Anxiety (HAS)
The Hospital Anxiety Scale (HAS), a self-assessment scale, was developed to detect states of, anxiety and emotional distress, used to screen for the presence of anxiety, in a general medical population of patients (Zigmond & Snaith, 1983). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety. For both scales, scores of less than 7 indicate normal, 8-10 indicate mild anxiety, 11-14 indicate moderate anxiety and 15-21 severe anxiety.
Full Information
NCT ID
NCT03752346
First Posted
October 31, 2018
Last Updated
November 21, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03752346
Brief Title
Multimodal Exercise Program on Parkinson's Disease Patients With Depression
Official Title
Effectiveness of Multimodal Exercise Program on Depression and Health-Related Quality of Life in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Depression symptoms are common in Parkinson's Disease, it affects health-related quality of life. The evidence showed that exercise improved depression and HRQOL in PD patients. However, studies rarely considered the appropriate exercise program for PD patients, we want to find the best exercise program for PD patients.
Detailed Description
Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression and HRQOL in PD Patients.
Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017. Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline, week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, A Multimodal Exercise Program, Aerobic Exercise, Depression, Health Related Quality of Life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group maintained their regular lifestyle and received the routine care
Arm Title
exercise group
Arm Type
Experimental
Arm Description
Participants in the exercise group (EG) were instructed to engage performed exercise at least 3 times per week (30-50 minutes) or 10-15 minutes per section every day to accumulate 150 minutes per week for 8 weeks using disc (DVD) at home. Main exercise was moderate intensity aerobic exercise, an intensity of 55-70% of the heart rate reserve (HR max).
Intervention Type
Other
Intervention Name(s)
exercise group
Intervention Description
A step aerobics exercise lasted a total 30 minutes, including:
a warm-up with 10 minutes of stretching exercises.
A step aerobics exercise (step aerobics for 30 minutes; step by step, step exercise, or stepping the ground repetitively)23,24 a total of 30 minutes then cool down (5 minutes).
Resistance training (10 minutes), stretching and relaxation for 10-15 minutes.
Primary Outcome Measure Information:
Title
GDS-15
Description
consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986). Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.
Time Frame
3 minutes
Title
PDQ-8
Description
A sub-set of items is then selected from the PDQ-39 to create a shorter form version, the PDQ-8 (Jenkinson, Fitzpatrick & Peto, 1997). The sum of the scores can provide a single figure used to assess the overall health-related quality of life profile of the individual questioned. . Scores for each dimension range from 0 to 100, PDQ-8SI scores can be standardized on a scale from 0 to 100, with lower scores indicating better HRQoL.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
UPDRS part II (ADL)
Description
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987). The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. A total of 199 points are possible (199 represents the worst disability and 0 no disability). Part II: self-evaluation of the activities of daily life (ADLs). The scales part 2: motor experiences of daily living (13 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame
5 minutes
Title
UPDRS part III (motor ability)
Description
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease (Fahn & Elton, 1987). The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. Its 42 items are evaluated by interview and clinical observation. The motor section in particular to follow the progression of a person's Parkinson's disease. A total of 199 points are possible (199 represents the worst disability and 0 no disability). The scales part 3: motor examination (18 items), each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame
10 minutes
Title
Fatigue (FSS)
Description
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989). The subject is asked to read each statement and circle a number from 1 to 7, the items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.
Time Frame
5 minutes
Title
Sleep quality (PSQI)
Description
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality.
Time Frame
5 minutes
Title
Anxiety (HAS)
Description
The Hospital Anxiety Scale (HAS), a self-assessment scale, was developed to detect states of, anxiety and emotional distress, used to screen for the presence of anxiety, in a general medical population of patients (Zigmond & Snaith, 1983). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety. For both scales, scores of less than 7 indicate normal, 8-10 indicate mild anxiety, 11-14 indicate moderate anxiety and 15-21 severe anxiety.
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be diagnosed PD in Hoehn and Yahr stage I-II22
under stable medication treatment at least 3 months
no disease limiting the patient's ability to perform the exercises
Exclusion Criteria:
severe cardiovascular disorders
neuromusculoskeletal disorder
cognitive impairment
recent participation in any physiotherapy or rehabilitation program
have exercise regularly
12. IPD Sharing Statement
Plan to Share IPD
No
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Multimodal Exercise Program on Parkinson's Disease Patients With Depression
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