Improvement of a Physically Active Lifestyle (FaBA)

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).

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Pain; Diabetes Mellitus, Type 2; Osteoarthritis; Rheumatoid Arthritis; Motivation; Behavior
• Intervention / Treatment: Behavioral: Intervention Group (IG); Behavioral: Active Control Group (ACG)

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.

• Study Type: Interventional
• Enrollment (Actual): 1377
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14195
    • Freie Universitaet Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Intervention Group (IG); patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients; Other Names: FaBA
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.	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 Names: MoVo
No Intervention: Passive Control Group (PCG); patients are asked to answer the questionnaires only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
physical activity	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
subjective health	18 months
quality of life	18 months
rehabilitation satisfaction	18 months
motivation	18 months
social-cognitive predictors of behavior (self-efficacy, action control etc.)	18 months

Collaborators and Investigators

• Sponsor: Freie Universität Berlin
• Collaborators: Deutsche Rentenversicherung
• Investigators: Principal Investigator: Sonia Lippke, PhD, Freie Universitaet Berlin

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (Estimate): September 18, 2009

Study Record Updates

• Last Update Posted (Estimate): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Rehabilitation; Randomized Controlled Trial; motivational interviewing; evidence- and theory-based behavioral intervention; expert system; stages of change; tailoring; Self Care; Expert Systems
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Heart Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 8011 - 106 - 31/31.91; 0421/00-40-64-50-00