Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)
2022年1月14日 更新者：Graziella Brinchault、University of Rennes 2
Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life.
Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern.
It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities).
Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects.
This alteration is associated with a greater functional limitation and a higher risk of falling.
Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life.
Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed.
The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised.
(2) Several clinical factors are associated with these changes.
調査の概要
状態
まだ募集していません
条件
研究の種類
観察的
入学 (予想される)
32
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Romain Pichon, MSc
- 電話番号：0667774267
- メール：r.pichon@ifpek.org
研究連絡先のバックアップ
- 名前：Armel Cretual, PhD
- メール：armel.cretual@univ-rennes2.fr
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
COPD patients that realize their medical follow-up at University Hospital of Rennes
説明
Inclusion Criteria:
- COPD patients GOLD stage 2 and 3 (A-D)
- In accordance with Article L1121-8-1 of the Public Health Code, participants must be affiliated to a social security scheme or benefit from such a scheme.
Exclusion Criteria:
- the presence of long-term or exercise-based oxygen therapy,
- the presence of a medically diagnosed pathology causing manifest disorders of balance,
- the inability to walk 150 m without stopping and to climb or descend stairs,
- a history of pneumonectomy or lobectomy within the last six months,
- the existence of an acute respiratory exacerbation within the last two months,
- the presence of obvious cognitive impairment that impairs comprehension of instructions,
- body mass index less than 21 or more than 35 kg/m².
Person referred to in articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the public health code:
- Pregnant woman, woman in labour or nursing mother
- Person deprived of liberty by judicial or administrative decision
- Person hospitalised without consent and not subject to a legal protection measure, and person admitted to a health or social establishment for purposes other than research
- Minor
- Person subject to a period of exclusion for other research
- Person of full age subject to a legal protection measure (guardianship, curatorship or safeguard of justice), person of full age unable to express their consent and not subject to a protection measure
- Person under psychiatric care
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
健康管理
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
|
COPD患者
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functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Margins of stability
時間枠：Clinical assessment at baseline
|
Postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
|
Clinical assessment at baseline
|
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Margins of stability variability
時間枠：Clinical assessment at baseline
|
Coefficient of variation of a postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
|
Clinical assessment at baseline
|
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Center of Mass velocity
時間枠：Clinical assessment at baseline
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Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
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Center of mass displacement
時間枠：Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evolution of articular angulations
時間枠：Clinical assessment at baseline
|
Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests
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Clinical assessment at baseline
|
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Centre of pressure (CoP) Area
時間枠：Clinical assessment at baseline
|
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Centre of pressure (CoP) velocity
時間枠：Clinical assessment at baseline
|
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Centre of pressure (CoP) variability
時間枠：Clinical assessment at baseline
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Coefficient of variation of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
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Clinical assessment at baseline
|
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Gait Cadence
時間枠：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
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Gait velocity
時間枠：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
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Gait phases duration
時間枠：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
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Step width
時間枠：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
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Clinical assessment at baseline
|
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Step length
時間枠：Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
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Clinical assessment at baseline
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Completion time of the Modified Glittre ADL
時間枠：Clinical assessment at baseline
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Time to complete the modified Glittre-ADL test
|
Clinical assessment at baseline
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Completion time of the timed up and go test
時間枠：Clinical assessment at baseline
|
Time to complete the timed up and go test test
|
Clinical assessment at baseline
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dyspnea assessment scale
時間枠：Clinical assessment at baseline
|
assessed by the modified Borg Scale which is a 0 to 10 scale (0 representing no dyspnea, 10 representing the worst imaginable dyspnea).
Dyspnea is assessed before, during and after the functional tests
|
Clinical assessment at baseline
|
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Heart rate
時間枠：Clinical assessment at baseline
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assessed before, during and after functional tests
|
Clinical assessment at baseline
|
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Leg discomfort scale
時間枠：Clinical assessment at baseline
|
assessed on a 0 to 10 scale (0 representing no discomfort, 10 representing the worst imaginable discomfort).Leg discomfort is assessed before, during and after the functional tests
|
Clinical assessment at baseline
|
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Visual analog scale for pain
時間枠：Clinical assessment at baseline
|
Pain is assessed by a visual analog scale which is a 100mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling (Here no pain and the worst imaginable pain)
|
Clinical assessment at baseline
|
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Pain Drawing scale
時間枠：Clinical assessment at baseline
|
participants are invited to identify on a body chart the location of experienced pain.
|
Clinical assessment at baseline
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Multi-dimensional dyspnea profile (MDP)
時間枠：Clinical assessment at baseline
|
Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea
|
Clinical assessment at baseline
|
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London chest activity of daily living questionnaire (LCADL)
時間枠：Clinical assessment at baseline
|
Dyspnea assessment tool which investigates the impact of dyspnea on 15 activities of daily living.
A score from 0 to 5 is given for each activity, 5 representing an higher impact of dyspnea on the activity.
|
Clinical assessment at baseline
|
|
Modified Medical Research Council Scale (MMRC)
時間枠：Clinical assessment at baseline
|
Dyspnea assessment tool which investigates impact of dyspnea in participants life.
This is a 0 to 4 scale with descriptors associated to each number.
4 representing the most severe impact of dyspnea.
|
Clinical assessment at baseline
|
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Charlson Index
時間枠：Clinical assessment at baseline
|
Comorbidities assessment tool which list 19 potential comorbidities associated with a weighted score.
The points are attributed when the comorbidity is present.
A total score is then calculated.
An higher score indicates an higher severity.
|
Clinical assessment at baseline
|
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Body composition
時間枠：Clinical assessment at baseline
|
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
|
Clinical assessment at baseline
|
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Maximal inspiratory pressure
時間枠：Clinical assessment at baseline
|
inspiratory muscles strength assessment
|
Clinical assessment at baseline
|
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Falls Efficacy Scale - International
時間枠：Clinical assessment at baseline
|
Fear of falling assessment tool which investigates fear of falling in 16 different activities.
Each activity is scored from 0 to 4 (4 representing an higher fear of falling in this activity).
The total score range from 16 to 64 (an higher score indicating a most severe fear of falling)
|
Clinical assessment at baseline
|
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Number of anterior falls
時間枠：Clinical assessment at baseline
|
assessment of fall occurence in the last 12 months
|
Clinical assessment at baseline
|
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General Practioner assessment of Cognition (GP-COG)
時間枠：Clinical assessment at baseline
|
assessment of cognitive function.
GP-COG gives a score from 0 to 9 (9 indicating a better cognitive function)
|
Clinical assessment at baseline
|
|
International Physical Activity Questionnaire (IPAQ short-form)
時間枠：Clinical assessment at baseline
|
assessment of daily physical activity and sedentarity
|
Clinical assessment at baseline
|
|
COPD assessment test (CAT)
時間枠：Clinical assessment at baseline
|
quality of life assessment tool
|
Clinical assessment at baseline
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Graziella Brinchault, MD、University Hospital of Rennes
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年2月1日
一次修了 (予想される)
2022年9月1日
研究の完了 (予想される)
2023年4月1日
試験登録日
最初に提出
2021年11月23日
QC基準を満たした最初の提出物
2022年1月14日
最初の投稿 (実際)
2022年1月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月27日
QC基準を満たした最後の更新が送信されました
2022年1月14日
最終確認日
2022年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。