The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital (OLPADIS)
2020年8月3日 更新者：Sylvia Sunde、Oslo Metropolitan University
Effect of a Multi-Component Exercise Program on Function and Health in Older People Recently Discharged From Hospital. A Randomized Controlled Clinical Trial.
The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital.
The intervention consists of 32 group-based exercise sessions, performed twice a week.
In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly.
The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above.
調査の概要
詳細な説明
Older people who have been hospitalized often experience loss of function, increased risk of falls and reduced health-related quality of life (HRQOL) in the post-discharge period.
The reason for this is the cumulative effect of illness, bedrest during hospital stay and inactivity after discharge.
Previous research indicates that exercise therapy should be an integrated part of the post-hospital treatment to prevent or postpone this functional decline and improve HRQOL.
Therefore, the investigators will conduct a randomized controlled trial to investigate the effect of a multi-component exercise program consisting of high intensity exercises on physical function, physical activity and HRQOL among older people living at home after discharge from hospital after treatment of an acute medical event.
研究の種類
介入
入学 (実際)
88
段階
- 適用できない
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。
研究場所
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Oslo、ノルウェー、0370
- Diakonhjemmet hospital
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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
65年歳以上 (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
説明
Inclusion Criteria:
- 65 years or older, live in their own home, consent to participate in the program three times a week (twice a week outside their home), manage to walk with or without assistive device, and assessed by a doctor as able to tolerate the intervention.
Exclusion Criteria:
- Severe cognitive impairment (Mini-Mental State Examination (MMSE) score less than 20), have an expected lifespan less than one year, exercise more than twice a week, and score above nine points on the Short Physical Performance Battery.
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
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Exercise
This group will perform a multi-component exercise program twice a week for 16 weeks.
The multi-component exercise program consists of endurance training, progressive strength exercises and balance exercises.
The intervention will be individualised, but performed in groups of four to ten patients.
The participants are also expected to do exercises on their own, at least once weekly.
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A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.
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介入なし：Control
The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization recommendations on physical activity for adults aged 65 and above.
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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 |
|---|---|---|
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Changes in physical function
時間枠：Baseline, 4 months and 8 months
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Changes in physical function will be measured with The Short Physical Performance Battery (SPPB).
This test evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together side-by side, semitandem and tandem positions, time to walk 8ft and time to rise from a chair and return to the seated position five times.
Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels.
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Baseline, 4 months and 8 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Berg Balance Scale
時間枠：Baseline, 4 months and 8 months
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Berg Balance Scale is a measure of performance-based balance.
It comprises 14 observable tasks frequently encountered in everyday life.
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Baseline, 4 months and 8 months
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Health-related quality of life (HRQOL)
時間枠：Baseline, 4 months and 8 months
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HRQOL measured by the Medical Outcome Study 36 Item Short-Form Health Survey (SF-36)
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Baseline, 4 months and 8 months
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Physical Activity measured by the short form of the International Physical Activity Questionnaire (IPAQ-SF)
時間枠：Baseline, 4 months and 8 months
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The IPAQ-SF includes seven questions about the time spent in vigorous- and moderate intensity activities, walking and sedentary activity.
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Baseline, 4 months and 8 months
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Muscle mass
時間枠：Baseline, 4 months and 8 months
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Muscle mass will be measured by bioimpedance
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Baseline, 4 months and 8 months
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Compliance to the intervention
時間枠：Eight months from baseline
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Participants will complete an activity diary where they are asked to report completion of exercise, non-protocol activity and any adverse events related to the exercise.
Patients are considered non-compliant if they have undertaken less than 50% of the prescribed exercise.
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Eight months from baseline
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Feasibility of the intervention
時間枠：Four months from baseline
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Adverse events will be registered as outlined by Oryet al. (2005) in the following four categories: falls, cardiovascular events, musculoskeletal injuries and health care utilization.
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Four months from baseline
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Amount of home-help services received
時間枠：Baseline, 4 months and 8 months
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If they receive any home care
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Baseline, 4 months and 8 months
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Handgrip strength
時間枠：Baseline, 4 months and 8 months
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Handgrip strength in kilograms measured using a hydraulic dynamometer
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Baseline, 4 months and 8 months
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Height
時間枠：Baseline
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Height will be measured in meters
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Baseline
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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。
捜査官
- 主任研究者：Therese Brovold, Phd、Oslo University College of Applied Science
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Associations between health-related quality of life and physical function in older adults with or at risk of mobility disability after discharge from the hospital. Eur Geriatr Med. 2021 Dec;12(6):1247-1256. doi: 10.1007/s41999-021-00525-0. Epub 2021 Jun 9.
- Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Effects of a multicomponent high intensity exercise program on physical function and health-related quality of life in older adults with or at risk of mobility disability after discharge from hospital: a randomised controlled trial. BMC Geriatr. 2020 Nov 11;20(1):464. doi: 10.1186/s12877-020-01829-9.
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
2016年9月29日
一次修了 (実際)
2020年1月30日
研究の完了 (実際)
2020年1月30日
試験登録日
最初に提出
2016年9月5日
QC基準を満たした最初の提出物
2016年9月13日
最初の投稿 (見積もり)
2016年9月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年8月4日
QC基準を満たした最後の更新が送信されました
2020年8月3日
最終確認日
2020年8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。
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