Aktiv i Sør: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Intervention group - telephone and print exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group - telephone and print exercise intervention<br>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 | Behavioral: Intervention group - telephone and print exercise intervention<br>* Intervention has previously been described.<br>|
| No Intervention: Control group<br>The control group (CG) were encouraged to continue previous lifestyle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Cardiorespiratory fitness at 6 months | Cardiorespiratory fitness was measured by a modified Balke protocol on a treadmill and registered in ml/kg/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. | 
| Change from Baseline Muscular endurance of the back extensors at 6 months | 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). | 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 Hand grip strength at 6 months | Hand grip strength was registered to the nearest 1 kilogram (kg) using a hydraulic dynamometer | 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 Neuromotor fitness at 6 months | 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). | 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 Muscular dynamic endurance of and the ability to stabilize the upper body at 6 months | 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. | 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 Flexibility of the hamstring musculature at 6 months | Flexibility of the hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box. | 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 Flexibility in the shoulder joint at 6 months | 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. | 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 Explosive power in the lower extremities at 6 months | Explosive power in the lower extremities was recorded to the nearest centimeter, using the vertical jump test. | 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 | 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. | 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 Waist circumference at 6 months | Waist circumference was registered using a measuring band and the mean of two measures was recorded to the nearest half-centimeter. | 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 | Fat percentage was measured using the bioimpedance machine InBody 720 and using skinfolds. Both registered body fat percentage. | 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 | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age was assessed by questionaire to the nearest whole year. | This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011. | 
| Gender | Gender was assessed using a questionnaire and outcome was either Female or male. | This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011 | 
| Educational level | Educational level was assessed using a questionnaire as one of four different levels | This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011 |