Aktiv i Sør: a Randomized Controlled Trial

Physical Activity Clinical Trial

— AiS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164239
• Other study ID #: Aktiv i Sør
• Status: Completed
• Phase: N/A
• First received: March 9, 2017
• Last updated: May 23, 2017
• Start date: April 1, 2011
• Est. completion date: February 1, 2012

Study information

• Verified date: May 2017
• Source: University of Agder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 1, 2012
• Est. primary completion date: October 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Intervention group - telephone and print exercise intervention
Intervention has previously been described.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Agder	Norwegian School of Sport Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity level	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
Other	Stage of change	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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
Secondary	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