Improvement of a Physically Active Lifestyle (FaBA)

This study has been completed.
Sponsor:
Collaborator:
Deutsche Rentenversicherung Bund (DRV; German Retirement Insurance)
Information provided by:
Freie Universität Berlin
ClinicalTrials.gov Identifier:
NCT00979719
First received: September 17, 2009
Last updated: November 13, 2012
Last verified: January 2011

September 17, 2009
November 13, 2012
October 2009
November 2011   (final data collection date for primary outcome measure)
physical activity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00979719 on ClinicalTrials.gov Archive Site
  • subjective health [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • rehabilitation satisfaction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • motivation [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • social-cognitive predictors of behavior (self-efficacy, action control etc.) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Improvement of a Physically Active Lifestyle
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pain
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Heart Diseases
  • Diabetes Mellitus, Type 2
  • Behavior
  • Motivation
  • Behavioral: Intervention Group (IG)
    patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
    Other Name: FaBA
  • Behavioral: Active Control Group (ACG)
    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.)
    Other Name: MoVo
  • Experimental: Intervention Group (IG)
    Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
    Intervention: Behavioral: Intervention Group (IG)
  • Placebo Comparator: Active Control Group (ACG)
    Patients 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.
    Intervention: Behavioral: Active Control Group (ACG)
  • No Intervention: Passive Control Group (PCG)
    patients are asked to answer the questionnaires only
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 1;53(3):182-7. Epub 2011 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1377
September 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • the participant not be of age
  • severe cognitive deficits
  • visual impairments (patients have to read at the PC)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00979719
8011 - 106 - 31/31.91, 0421/00-40-64-50-00
Yes
Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin
Freie Universität Berlin
Deutsche Rentenversicherung Bund (DRV; German Retirement Insurance)
Principal Investigator: Sonia Lippke, PhD Freie Universitaet Berlin
Freie Universität Berlin
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP