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Metabolic Costs of Daily Activities in Older Adults (CHORES-XL)

2019年6月6日 更新者:University of Florida
The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments.

調査の概要

状態

完了

条件

詳細な説明

The work will evaluate the metabolic costs for daily activities across the lifespan and evaluate the influence of having functional impairments. The project will simultaneously conduct a cross-sectional and a case-control study. The primary aim will investigate cross-sectional association between older age and the energy expenditure of daily activities by recruiting approximately 25 adults in each of 7 age groups (20-30,30-40,40-50,50-60,60-70,70-80,80+) for a total of 180 individuals. A secondary aim will investigate the effect of functional impairments on the energy expenditure of daily activities by conducting a case-control study. An additional 25 older adults with functional impairment will be recruited in each age decade (60-70, 70-80, and 80+ years old) to accomplish this aim. Additional outcomes will evaluate rating of perceived exertion differences in daily activities. A tertiary aim will investigate using accelerometers to predict the metabolic costs of daily activities.

研究の種類

観察的

入学 (実際)

269

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

    • Florida
      • Gainesville、Florida、アメリカ、32611
        • UF Institute on Aging Clinical and Translational Research Building

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

20年歳以上 (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

Community dwelling population

説明

Inclusion Criteria:

  • Age 20+ years old
  • Community dwelling adults without significant health issues
  • Willingness to undergo all testing procedures
  • Weight stable for at least three months
  • Able to understand and speak English

Exclusion Criteria:

  • Failure to provide informed consent
  • A 10% enrollment limit will be applied to avid exercisers in each age decade. Avid exercises will be defined as doing structured exercise 3 or more days per week (e.g. jogging, sports etc., walkers will be permitted in the study). Based on our experience, avid exercisers volunteer for this type of research at a high rate and thus the investigators will limit these individuals to prevent a biased comparison
  • Use of walker (use of a cane is permitted)
  • Lower extremity amputation
  • Develops chest pain or severe shortness of breath during physical stress
  • Post-stroke syndrome causing ambulatory deficits (other stroke survivors permitted)
  • Pacemaker
  • Needs assistance with basic activities of daily living: feeding, dressing, continence, bathing, toileting, and transferring from a bed to a chair or from a chair to walking
  • Lives in a nursing home; persons living in assisted or independent housing are not excluded
  • For adults over the age of 60: >2 errors on the Short, portable mental status questionnaire administered after written informed consent
  • Excessive alcohol or substance abuse within six months or consumption of >14 alcohol drinks/week
  • For women who are child-bearing age (up to 62 years of age): pregnant or breast-feeding
  • Participation in a structured weight loss program or fad diet in the last month;
  • Weight reduction surgery in the past year
  • Known neuromuscular disorder (Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, chronic fatigue syndrome etc.)
  • Diagnosed neuropathy that causes pain
  • Symptomatic peripheral arterial disease
  • Unable to communicate because of severe hearing loss or speech disorder
  • Severe visual impairment, which would preclude completion of the assessments
  • Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, Multiple Sclerosis, Amyotrophic lateral sclerosis
  • Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; self-reported severe osteoarthritis
  • Terminal illness, as determined by the participant
  • Severe pulmonary disease, requiring the use of supplemental oxygen or steroid therapy
  • Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
  • Other significant comorbid disease discovered during medical screening, e.g. renal failure on hemodialysis, psychiatric disorder (e.g. bipolar, schizophrenia); chronic fatigue syndrome etc…
  • Liver diseases: chronic hepatitis, an inflammatory disease, or cirrhosis
  • Pregnancy. Participants within childbearing age will have a pregnancy test.
  • Contraindications to graded exercise testing according to the American Thoracic Society:
  • Acute myocardial infarction (<6 months since event)
  • Unstable angina
  • Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  • Syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremity
  • Suspected dissecting aneurysm
  • Uncontrolled asthmas
  • Pulmonary edema
  • Room air desaturation at rest < 85%
  • Respiratory failure
  • Acute non cardiopulmonary disorder that may affect exercise performance

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

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
MET value
時間枠:Participants will attend up to 4 visits within one month of enrollment to attain these data
MET value of physical activities defined as the oxygen uptake (VO2 = milliliter• min-1•kg-1) during a steady state rate expressed as a function 3.5 milliliter• min-1•kg-1.
Participants will attend up to 4 visits within one month of enrollment to attain these data
Metabolic economy
時間枠:Participants will attend up to 4 visits within one month of enrollment to attain these data
Metabolic economy is the energy expended for a given work rate.
Participants will attend up to 4 visits within one month of enrollment to attain these data
Relative metabolic cost to peak energy expenditure
時間枠:Participants will attend up to 4 visits within one month of enrollment to attain these data
Relative metabolic cost is function of peak oxygen consumption
Participants will attend up to 4 visits within one month of enrollment to attain these data
Relative metabolic cost to resting energy expenditure
時間枠:Participants will attend up to 4 visits within one month of enrollment to attain these data
Relative metabolic cost as a function of resting
Participants will attend up to 4 visits within one month of enrollment to attain these data

二次結果の測定

結果測定
メジャーの説明
時間枠
Rating of perceived exertion
時間枠:Participants will attend up to 4 visits within one month of enrollment to attain these data
Ratings of perceived exertion will be collected during all activities. Investigators will use the Category Ratio scale-10 scale developed by Borg in 1982.
Participants will attend up to 4 visits within one month of enrollment to attain these data

その他の成果指標

結果測定
メジャーの説明
時間枠
Accelerometer signals to predict of energy expenditure
時間枠:Participants will attend up to 4 visits within one month of enrollment to attain these data
A tertiary outcome is to validate body worn monitors (e.g. accelerometers) to estimate the type and intensity of activity for accurate estimation of energy expenditure. A predicted metabolic equivalent value will be estimated for each activity.
Participants will attend up to 4 visits within one month of enrollment to attain these data

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:Todd M Manini, PhD、University of Florida

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。

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

2014年7月1日

一次修了 (実際)

2019年6月6日

研究の完了 (実際)

2019年6月6日

試験登録日

最初に提出

2014年2月28日

QC基準を満たした最初の提出物

2014年4月30日

最初の投稿 (見積もり)

2014年5月2日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月7日

QC基準を満たした最後の更新が送信されました

2019年6月6日

最終確認日

2019年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB201501057-N
  • 5R01AG042525-05 (米国 NIH グラント/契約)
  • 087-2013 (その他の識別子:Univeristy of Florida)
  • OCR15164 (その他の識別子:University of Florida)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

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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