Aktiv i Sør: a Randomized Controlled Trial (AiS)
2017년 5월 23일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
111
단계
- 해당 없음
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
40년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
|
Intervention has previously been described.
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간섭 없음: Control group
The control group (CG) were encouraged to continue previous lifestyle.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline Cardiorespiratory fitness at 6 months
기간: 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 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
기간: 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.
|
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
기간: 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.
|
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
기간: 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
기간: 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.
|
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
기간: 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
기간: 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.
|
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
기간: 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.
|
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.
|
|
Change from Baseline Body mass index at 6 months
기간: 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.
|
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
기간: 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.
|
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.
|
|
Change from Baseline Fat percentage at 6 months
기간: 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.
|
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.
|
|
Change from Baseline Cardiorespiratory fitness at 6 months
기간: 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.
|
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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Age
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical activity level
기간: 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
|
Physical activity level was assessed using IPAQ- sf as minutes of physical activity per week.
|
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
기간: 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
|
Stage of change was assessed using a questionnaire as one of five alternatives.
|
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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Monica K Torstveit, PhD, University of Agder
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2011년 4월 1일
기본 완료 (실제)
2011년 10월 1일
연구 완료 (실제)
2012년 2월 1일
연구 등록 날짜
최초 제출
2017년 3월 9일
QC 기준을 충족하는 최초 제출
2017년 5월 19일
처음 게시됨 (실제)
2017년 5월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 23일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Aktiv i Sør
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
The IPD of the present study will be shared through publications (articles).
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
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. .
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