Aktiv i Sør: a Randomized Controlled Trial (AiS)
2017年5月23日 更新者：Monica Klungland Torstveit、University of Agder
The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial
The purpose of this regional parallel-group RCT was to assess the effect of a six-month tailored telephone and email based physical activity intervention on various measures of physical fitness and body composition in a sample of physically inactive adults.
A total of 111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either an intervention group (IG;n=56) or a no-intervention control group (CG;n=55).
The IG received tailored exercise recommendations, every two months by email or mail (print) in addition to motivational follow-ups every second week, alternatively by email and telephone.
Primary outcome measures were various objective measures of musculoskeletal and cardiorespiratory fitness in addition to various measures of body composition, including waist circumference, body mass index and fat percentage, which were assessed pre- and post-intervention.
調査の概要
研究の種類
介入
入学 (実際)
111
段階
- 適用できない
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
40年～55年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Participants were included in the study if they were
- healthy
- between the ages of 40-55
- residents of the Agder counties in Norway
- classified as physically inactive (not fulfill the recommendations for physical activity given by the Norwegian Directorate of Health
- within stage one to three of the five stages of change in the transtheoretical model stages of change
Exclusion Criteria:
Participants were excluded if they were
- Unhealthy/ill
- younger than 40 years or older than 55 years
- living outside the Agder counties in Norway
- allready fulfilling the national recommendations given by the Norwegian Directorate of Health
- within stage four or five of the five stages of change in the transtheoretical model stages of change
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：Intervention group - telephone and print exercise intervention
The intervention group (IG) received a total of three intervention packages, one every second month, during the intervention period.
The first intervention package was distributed at intervention start.
The intervention package consisted of a tailored exercise program, national recommendations for physical activity, prompts and reminders.
Additionally the IG received fortnightly supportive motivational contact every two weeks, alternately by telephone og email
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Intervention has previously been described.
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介入なし：Control group
The control group (CG) were encouraged to continue previous lifestyle.
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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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Change from Baseline Cardiorespiratory fitness at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Cardiorespiratory fitness was measured by a modified Balke protocol on a treadmill and registered in ml/kg/min
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Muscular endurance of the back extensors at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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The static back extension test recorded muscular endurance of the back extensors as number of seconds the subject managed to endure a static horizontal position, with their lower body supported by a bench (max 240 sec).
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Hand grip strength at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Hand grip strength was registered to the nearest 1 kilogram (kg) using a hydraulic dynamometer
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Neuromotor fitness at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Neuromotor fitness was registered using the one leg standing test where the duration each subject managed to hold a balancing position was recorded in seconds (max 60 seconds).
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Muscular dynamic endurance of and the ability to stabilize the upper body at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Muscular dynamic endurance of and the ability to stabilize the upper body was registered using a modified push-ups test.
The amount of correctly performed repetitions completed in 40 seconds, was recorded in number.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Flexibility of the hamstring musculature at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Flexibility of the hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Flexibility in the shoulder joint at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Flexibility of the shoulder joint was registered to the nearest centimeter, using the back-scratch test.
The mean registered flexibility score of both shoulders was recorded.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Explosive power in the lower extremities at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Explosive power in the lower extremities was recorded to the nearest centimeter, using the vertical jump test.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Body mass index at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Body mass index was calculated using the formula weight/height^2.
Height and weight were measured using a measuring band (meters) and a weight scale (kilograms) respectively.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Waist circumference at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Waist circumference was registered using a measuring band and the mean of two measures was recorded to the nearest half-centimeter.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Fat percentage at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Fat percentage was measured using the bioimpedance machine InBody 720 and using skinfolds.
Both registered body fat percentage.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Cardiorespiratory fitness at 6 months
時間枠：Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Cardiorespiratory fitness was measure by a modified Balke protocol on a treadmill and registered in l/min.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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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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Age
時間枠：This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
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Age was assessed by questionaire to the nearest whole year.
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
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Gender
時間枠：This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Gender was assessed using a questionnaire and outcome was either Female or male.
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Educational level
時間枠：This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Educational level was assessed using a questionnaire as one of four different levels
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical activity level
時間枠：This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Physical activity level was assessed using IPAQ- sf as minutes of physical activity per week.
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This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Stage of change
時間枠：This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Stage of change was assessed using a questionnaire as one of five alternatives.
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This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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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。
スポンサー
捜査官
- 主任研究者：Monica K Torstveit, PhD、University of Agder
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 (実際)
2011年4月1日
一次修了 (実際)
2011年10月1日
研究の完了 (実際)
2012年2月1日
試験登録日
最初に提出
2017年3月9日
QC基準を満たした最初の提出物
2017年5月19日
最初の投稿 (実際)
2017年5月23日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月25日
QC基準を満たした最後の更新が送信されました
2017年5月23日
最終確認日
2017年5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
- Aktiv i Sør
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?
いいえ
IPD プランの説明
The IPD of the present study will be shared through publications (articles).
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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。
Intervention group - telephone and print exercise interventionの臨床試験
-
University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)完了