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Aktiv i Sør: a Randomized Controlled Trial

Not Applicable
Completed
Conditions
Physical Activity
Interventions
Behavioral: Intervention group - telephone and print exercise intervention
Registration Number
NCT03164239
Lead Sponsor
University of Agder
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
111
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention group - telephone and print exercise interventionIntervention group - telephone and print exercise interventionThe 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
Primary Outcome Measures
NameTimeMethod
Change from Baseline Waist circumference at 6 monthsData 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.

Change from Baseline Cardiorespiratory fitness at 6 monthsData 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.

Change from Baseline Muscular endurance of the back extensors at 6 monthsData 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).

Change from Baseline Hand grip strength at 6 monthsData 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

Change from Baseline Neuromotor fitness at 6 monthsData 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.

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).

Change from Baseline Muscular dynamic endurance of and the ability to stabilize the upper body at 6 monthsData 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.

Change from Baseline Flexibility of the hamstring musculature at 6 monthsData 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 hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box.

Change from Baseline Flexibility in the shoulder joint at 6 monthsData 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.

Change from Baseline Explosive power in the lower extremities at 6 monthsData 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.

Change from Baseline Body mass index at 6 monthsData 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.

Change from Baseline Fat percentage at 6 monthsData 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.

Secondary Outcome Measures
NameTimeMethod
AgeThis is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.

Age was assessed by questionaire to the nearest whole year.

GenderThis is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011

Gender was assessed using a questionnaire and outcome was either Female or male.

Educational levelThis 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 was assessed using a questionnaire as one of four different levels

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