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Completed

NCT Number: NCT03164239

Aktiv i Sør: 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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group - telephone and print exercise intervention

Behavioral

Intervention has previously been described.

Primary outcomes

  1. Change from Baseline Cardiorespiratory fitness at 6 months

    Time frame: 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

  2. Change from Baseline Muscular endurance of the back extensors at 6 months

    Time frame: 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).

  3. Change from Baseline Hand grip strength at 6 months

    Time frame: 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

  4. Change from Baseline Neuromotor fitness at 6 months

    Time frame: 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.

    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).

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

    Time frame: 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.

  6. Change from Baseline Flexibility of the hamstring musculature at 6 months

    Time frame: 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 hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box.

  7. Change from Baseline Flexibility in the shoulder joint at 6 months

    Time frame: 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.

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

    Time frame: 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.

  9. Change from Baseline Body mass index at 6 months

    Time frame: 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.

  10. Change from Baseline Waist circumference at 6 months

    Time frame: 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.

  11. Change from Baseline Fat percentage at 6 months

    Time frame: 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.

  12. Change from Baseline Cardiorespiratory fitness at 6 months

    Time frame: 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.

Secondary outcomes

  1. Age

    Time frame: This 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.

  2. Gender

    Time frame: 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 was assessed using a questionnaire and outcome was either Female or male.

  3. Educational level

    Time frame: 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 was assessed using a questionnaire as one of four different levels

Other outcomes

  1. Physical activity level

    Time frame: 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.

  2. Stage of change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Agder

Other

Collaborators

  • Norwegian School of Sport Sciences

Registry information

Official study title

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

Acronym: AiS

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 23, 2017
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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