AzTrials
AzTrials

PainFaBANCT00979719

Improvement of a Physically Active Lifestyle

A study testing Intervention Group (IG) in people with Pain and Osteoarthritis, run by Freie Universität Berlin at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is imperative to increase self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a well established standard program and a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain, Osteoarthritis, Rheumatoid Arthritis
What is being tested?
Intervention Group (IG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,377 participants
Where
1 siteGermany
Study dates
Oct 2009to Sep 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • to be capable of exercising on their own at the minimum level recommended by the according rehabilitation clinic
  • able to fill out a questionnaire (no illiteracy)
  • adequate German language ability

Who cannot join

  • the participant not be of age
  • severe cognitive deficits
  • visual impairments (patients have to read at the PC)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Freie Universitaet Berlin

    Berlin, State of Berlin, 14195

Other trials in Germany

About this study

Official title: Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System

To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is imperative to increase self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a well established standard program and a questionnaire-only group. Rehabilitation patients will be treated psychologically and followed up over 18 months. The computerized expert system is expected to help patients better than the standard program. Both interventions are hypothesized to improve self-management competencies over and above the rehabilitation treatment (i.e., questionnaire-only group).

Read the detailed description

An experimental study with three groups is planned over a time period of 18 months. Patients in the intervention group receive an interactive, computerized expert system (Intervention Group, IG). Patients in the Active Control Group (ACG) get an interactive computerized standard program. This standard program has already been proven to be effective but which does not tailor treatment components to the individual needs of the patients. Patients in the Passive Control Group (PCG) are asked to answer the questionnaires only. Rehabilitation patients (N = 1000) will be recruited in three rehabilitation clinics and followed up over six measurement points: t1 and t2 with computer interventions during their rehabilitation stay; t3 and t4 with booster-sessions via telephone (6 weeks and 6 months after admission from rehabilitation). Furthermore, patients will be contacted at t5 per mail with motivational material (12 months after admission) and at t6 again per mail (only questionnaire, 18 months after admission).

The hypotheses are: In comparison to the PCG, both the IG and the ACG are expected to have a higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be less likely to relapse into previous unhealthy routines. Also, IG and ACG will be healthier as well as they will report more quality of life and rehabilitation satisfaction. In comparison to ACG, the IG is hypothesized to be more effective than the ACG regarding motivation, behavior and social-cognitive predictors of behavior. Moreover, the interventions (ACG and IG) are supposed to be equally effective for cardiac and orthopedic, as well as out-patient and stationary treated rehabilitation patients. After successful evaluation and some adoptions the intervention will be implemented as a self-help program in all eligible rehabilitation clinics and in the internet.

Being tested
Intervention Group (IG), Active Control Group (ACG)
Keywords
Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Rehabilitation, Expert Systems
Medical subject headings
Pain, Osteoarthritis, Arthritis, Rheumatoid, Heart Diseases, Diabetes Mellitus, Type 2, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention Group (IG)Behavioural

    Also called FaBA

    patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

  • Active Control Group (ACG)Behavioural

    Also called MoVo

    Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, W. \& Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.)

Study groups in NCT00979719
Study groupRoleWhat they receive
Intervention Group (IG)ExperimentalPatients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Receives: Behavioral: Intervention Group (IG)
Active Control Group (ACG)Placebo comparatorPatients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, \& Fuchs, 2007) Göhner, W. \& Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.
Receives: Behavioral: Active Control Group (ACG)
Passive Control Group (PCG)No interventionpatients are asked to answer the questionnaires only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. physical activity

    Measured: 18 months

Secondary outcomes (5)

  1. subjective health

    Measured: 18 months

  2. quality of life

    Measured: 18 months

  3. rehabilitation satisfaction

    Measured: 18 months

  4. motivation

    Measured: 18 months

  5. social-cognitive predictors of behavior (self-efficacy, action control etc.)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2011
  4. Study completionSep 2012

Resources

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
1,377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979719
Sponsor's protocol ID
8011 - 106 - 31/31.91
Other IDs
0421/00-40-64-50-00
Acronym
FaBA
Status last verified
Jan 2011
First submitted
17 Sep 2009
Last updated
15 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Lippke S, Pomp S, Fleig L. Rehabilitants' conscientiousness as a moderator of the intention-planning-behavior chain. Rehabil Psychol. 2018 Aug;63(3):460-467. doi: 10.1037/rep0000210.

    PubMed 30113201

  • Fleig L, Kerschreiter R, Schwarzer R, Pomp S, Lippke S. 'Sticking to a healthy diet is easier for me when I exercise regularly': cognitive transfer between physical exercise and healthy nutrition. Psychol Health. 2014;29(12):1361-72. doi: 10.1080/08870446.2014.930146. Epub 2014 Jul 21.

    PubMed 24894668

  • Fleig L, Lippke S, Pomp S, Schwarzer R. Intervention effects of exercise self-regulation on physical exercise and eating fruits and vegetables: a longitudinal study in orthopedic and cardiac rehabilitation. Prev Med. 2011 Sep;53(3):182-7. doi: 10.1016/j.ypmed.2011.06.019. Epub 2011 Jul 14.

    PubMed 21784096

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group (IG) in people with Pain and Osteoarthritis, run by Freie Universität Berlin at 1 site in Germany.

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 3 inclusion and 3 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 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

physical activity (time frame: 18 months). 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 NCT00979719, which also lists 3 linked publications.

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 15 Nov 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in