Aktiv i Sør: a Randomized Controlled Trial

NCT03164239 | Completed DMC

• 1 other identifier: Aktiv i Sør
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Age

  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

  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

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

Other Outcomes (2)

• Physical activity level

  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

  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

Study Arms (2)

Intervention group - telephone and print exercise intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group (CG) were encouraged to continue previous lifestyle.

Interventions

Intervention group - telephone and print exercise intervention BEHAVIORAL

Intervention has previously been described.

Intervention group - telephone and print exercise intervention

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Agder: lead
• Norwegian School of Sport Sciences: collaborator

Related Publications (1)

• Kjaer IGH, Anderssen SA, Torstveit MK. A tailored telephone and email based exercise intervention induced reductions in various measures of body composition in physically inactive adults: A randomized controlled trial. Prev Med Rep. 2018 Jun 27;11:160-168. doi: 10.1016/j.pmedr.2018.06.011. eCollection 2018 Sep.

  PMID: 29988751 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Monica K Torstveit, PhD

  University of Agder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: May 23, 2017
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: February 1, 2012
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share