Physical ActivityAiSNCT03164239
Aktiv i Sør: a Randomized Controlled Trial
A study testing Intervention group - telephone and print exercise intervention in people with Physical Activity, run by University of Agder.
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. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Intervention group - telephone and print exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2011to 1 Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: 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.
- Conditions
- Physical Activity
- Being tested
- Intervention group - telephone and print exercise intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group - telephone and print exercise interventionBehavioural
Intervention has previously been described.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intervention group - telephone and print exercise intervention |
| Control group | No intervention | The control group (CG) were encouraged to continue previous lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Age was assessed by questionaire to the nearest whole year.
Measured: 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.
Measured: 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
Measured: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Apr 2011
- Primary completion1 Oct 2011
- Study completion1 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Agder
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Monica Klungland Torstveit, University of Agder
- Investigators
- Monica K Torstveit, PhD, Principal investigator, University of Agder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164239
- Sponsor's protocol ID
- Aktiv i Sør
- Acronym
- AiS
- Status last verified
- May 2017
- First submitted
- 9 Mar 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD of the present study will be shared through publications (articles).
Publications
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.
PubMed 29988751
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03164239
- Acronym / sponsor ID
- AiS / Aktiv i Sør
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of AgderUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 1 Oct 2011 (actual)
- Study completion
- 1 Feb 2012 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - telephone and print exercise intervention | Experimental | Behavioral: Intervention 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 |
| Control group | No intervention | –The control group (CG) were encouraged to continue previous lifestyle. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group - telephone and print exercise interventionIntervention has previously been described. | Behavioural | Intervention group - telephone and print exercise intervention |
Primary outcome
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
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).
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
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).
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Derived from this study: PubMed 29988751Kjaer 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.
- Individual participant dataSharing planned: No. The IPD of the present study will be shared through publications (articles).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica K Torstveit, PhD principal investigator
University of Agder
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group - telephone and print exercise intervention in people with Physical Activity, run by University of Agder.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.