Clinical trial NCT00979719: Improvement of a Physically Active Lifestyle
Official title: Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Freie Universität Berlin
Sponsor class: OTHER
Collaborators: name: Deutsche Rentenversicherung
First posted: 2009-09-18
Enrollment: 1377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: physical activity
timeFrame: 18 months
Secondary outcomes:
measure: subjective health
timeFrame: 18 months
measure: quality of life
timeFrame: 18 months
measure: rehabilitation satisfaction
timeFrame: 18 months
measure: motivation
timeFrame: 18 months
measure: social-cognitive predictors of behavior (self-efficacy, action control etc.)
timeFrame: 18 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Freie Universitaet Berlin
Study officials:
affiliation: Freie Universitaet Berlin
name: Sonia Lippke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.