Preventive Program in Multiple Sclerosis
2021년 1월 27일 업데이트: Kamila Řasová
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life.
The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.
연구 개요
상태
완전한
정황
상세 설명
The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive program, which included individual physiotherapy focused on the treatment of functional disorders of the loco-motor system and therapy on a neurophysiological basis, group psychotherapy and controlled aerobic training.
The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart.
Influence on physical fitness (spiroergometric examination), fatigue (Modify Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck scale for evaluation of depression), admission of disease RS (Inventory of admission of multiple sclerosis, quality of life) life and selected neurohormones (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).
연구 유형
중재적
등록 (실제)
17
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Praha, 체코, 128 00
- Kamila Řasová
-
-
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- definite MS
- stable clinical status in the preceding 3 months
- imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab)
- Expanded Disability Status Scale (EDSS)≤6
- predominant motor impartment
- six months or more without any physiotherapy
- ability to undergo ambulatory physiotherapy
Exclusion Criteria:
- other neurological disease or conditions disabling movement
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise
|
Preventive program included informations of the possibilities of physiotherapy in the treatment of multiple sclerosis focused on fatigue management - recommending lifestyle changes.
Program included a the treatment of psychosomatic, viscerosomatic functional disorders by reflexively poor connection through the locomotor system using computer kinesiology, psychotherapy, manual therapy - where patients are corrected into a postural position and the joints are functionally centred, and aerobic exercise to influence fatigue and improve the performance of the cardiovascular system.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Questionnaires - The Fatigue scale for motor and cognitive functions
기간: change after six months of the program and after next six moths without therapy is being assessed
|
FSMC - is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Questionnaires - The Satisfaction With Life Scale
기간: change after six months of the program and after next six moths without therapy is being assessed
|
The scale measures the current level of satisfaction with one's own life.
Investigators express the extent to which they agree or disagree with the five statements.
The rating scale contains 7 points (1- "strongly disagree" and 7 - "strongly agree").
The maximum number of points on the scale is 35 (maximum satisfaction with your life) and the minimum number of points is 5 (dissatisfaction with your life).
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Questionnaires - Multiple Sclerosis Acceptance Questionnaire
기간: change after six months of the program and after next six moths without therapy is being assessed
|
This questionnaire consists of 20 statements that relate to the lives of patients with MS.
The rating scale has seven points (1- "never pays" to 7 - "always pays").
The minimum value is 20 (minimum adaptation to the diagnosis of MS for a large limitation of the normal life of MS) and the maximum value is 140 points (maximum adaptation to the diagnosis of MS - without the limitation of the normal life of MS) .
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Questionnaires - Beck Depression Inventory Score
기간: change after six months of the program and after next six moths without therapy is being assessed
|
questionnaire is divided into thirteen categories and patients select a statement in each category which best fits their current feelings on the scale ranged from 0 (the best feelings) to 3 (the worst feelings).
The maximum value of the total scale is 39 and shows the worst feeling of the person.
|
change after six months of the program and after next six moths without therapy is being assessed
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Ventilation capacity
기간: change after six months of the program and after next six moths without therapy is being assessed
|
Forced vital capacity = FVC [ l ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Metabolic utilization
기간: change after six months of the program and after next six moths without therapy is being assessed
|
maximal muscle performance = Rmax [ Watt kg-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Maximal oxygen uptake
기간: change after six months of the program and after next six moths without therapy is being assessed
|
VO2 kg-1 [ VO2max.kg-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Maximal oxygen pulse
기간: change after six months of the program and after next six moths without therapy is being assessed
|
VO2 HR-1 kg-1 [ VO2max.TF-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Relative ventilation
기간: change after six months of the program and after next six moths without therapy is being assessed
|
[ VEmax.kg-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Cortisol
기간: change after six months of the program and after next six moths without therapy is being assessed
|
levels of cortisol [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Cortizone
기간: change after six months of the program and after next six moths without therapy is being assessed
|
levels of cortisone[ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
Dehydroepiandrosterone (DHEA)
기간: change after six months of the program and after next six moths without therapy is being assessed
|
levels of DHEA [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
기간: change after six months of the program and after next six moths without therapy is being assessed
|
levels of 7β-OH-DHEA [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
|
7-oxo dehydroepiandrosterone (7-oxo-DHEA )
기간: change after six months of the program and after next six moths without therapy is being assessed
|
levels of 7-oxo-DHEA [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Questionnaires - Modified Fatigue Impact Scale
기간: change after six months of the program and after next six moths without therapy is being assessed
|
This scale consists of 21 statements that describe how often fatigue has affected a person during last four weeks.
Each statement is ranged from 0 (never) to 4 (almost, always).
The maximum value of the scale is 84.
|
change after six months of the program and after next six moths without therapy is being assessed
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
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)
2017년 10월 1일
기본 완료 (실제)
2019년 10월 1일
연구 완료 (실제)
2019년 10월 1일
연구 등록 날짜
최초 제출
2020년 11월 20일
QC 기준을 충족하는 최초 제출
2020년 12월 9일
처음 게시됨 (실제)
2020년 12월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 2월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 27일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EK-VP/25/0/2014
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
다발성 경화증에 대한 임상 시험
-
University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스