Multimodal Exercise Program on Parkinson's Disease Patients With Depression
2018년 11월 21일 업데이트: Chang Gung Memorial Hospital
Effectiveness of Multimodal Exercise Program on Depression and Health-Related Quality of Life in Patients With Parkinson's Disease
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
98
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: control group
Control group maintained their regular lifestyle and received the routine care
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실험적: exercise group
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).
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A step aerobics exercise lasted a total 30 minutes, including:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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GDS-15
기간: 3 minutes
|
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.
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3 minutes
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PDQ-8
기간: 3 minutes
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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.
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3 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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UPDRS part II (ADL)
기간: 5 minutes
|
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.
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5 minutes
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UPDRS part III (motor ability)
기간: 10 minutes
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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.
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10 minutes
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Fatigue (FSS)
기간: 5 minutes
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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.
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5 minutes
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Sleep quality (PSQI)
기간: 5 minutes
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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.
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5 minutes
|
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Anxiety (HAS)
기간: 3 minutes
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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.
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3 minutes
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 3월 1일
기본 완료 (실제)
2017년 1월 1일
연구 완료 (실제)
2017년 1월 1일
연구 등록 날짜
최초 제출
2018년 10월 31일
QC 기준을 충족하는 최초 제출
2018년 11월 21일
처음 게시됨 (실제)
2018년 11월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 11월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 11월 21일
마지막으로 확인됨
2018년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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