search
Back to results

Improvement of a Physically Active Lifestyle (FaBA)

Primary Purpose

Pain, Osteoarthritis, Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intervention Group (IG)
Active Control Group (ACG)
Sponsored by
Freie Universität Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Rehabilitation, Expert Systems

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Freie Universitaet Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Intervention Group (IG)

Active Control Group (ACG)

Passive Control Group (PCG)

Arm Description

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

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.

patients are asked to answer the questionnaires only

Outcomes

Primary Outcome Measures

physical activity

Secondary Outcome Measures

subjective health
quality of life
rehabilitation satisfaction
motivation
social-cognitive predictors of behavior (self-efficacy, action control etc.)

Full Information

First Posted
September 17, 2009
Last Updated
November 13, 2012
Sponsor
Freie Universität Berlin
Collaborators
Deutsche Rentenversicherung
search

1. Study Identification

Unique Protocol Identification Number
NCT00979719
Brief Title
Improvement of a Physically Active Lifestyle
Acronym
FaBA
Official Title
Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Freie Universität Berlin
Collaborators
Deutsche Rentenversicherung

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteoarthritis, Rheumatoid Arthritis, Heart Diseases, Diabetes Mellitus, Type 2, Behavior, Motivation
Keywords
Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Rehabilitation, Expert Systems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Arm Title
Active Control Group (ACG)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Passive Control Group (PCG)
Arm Type
No Intervention
Arm Description
patients are asked to answer the questionnaires only
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (IG)
Other Intervention Name(s)
FaBA
Intervention Description
patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Intervention Type
Behavioral
Intervention Name(s)
Active Control Group (ACG)
Other Intervention Name(s)
MoVo
Intervention Description
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.)
Primary Outcome Measure Information:
Title
physical activity
Time Frame
18 months
Secondary Outcome Measure Information:
Title
subjective health
Time Frame
18 months
Title
quality of life
Time Frame
18 months
Title
rehabilitation satisfaction
Time Frame
18 months
Title
motivation
Time Frame
18 months
Title
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Lippke, PhD
Organizational Affiliation
Freie Universitaet Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freie Universitaet Berlin
City
Berlin
ZIP/Postal Code
14195
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30113201
Citation
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.
Results Reference
derived
PubMed Identifier
24894668
Citation
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.
Results Reference
derived
PubMed Identifier
21784096
Citation
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.
Results Reference
derived

Learn more about this trial

Improvement of a Physically Active Lifestyle

We'll reach out to this number within 24 hrs