Trial document




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  DRKS00014814

Trial Description

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Title

A group- and smartphone-based psychological intervention to increase physical activity in patients with musculoskeletal conditions: A randomised controlled trial

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Trial Acronym

MoVo-App

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URL of the Trial

http://www.sport.uni-freiburg.de/de/institut/Arbeitsbereiche/psychologie/wirksamkeit-des-app-unterstuetzten-kleingruppenprogramms-movo-lisa-zur-steigerung-und-aufrechterhaltung-der-koerperli-chen-aktivitaet-bei-chronischen-schmerzen-eine-randomisierte-kontrollierte-studie

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Brief Summary in Lay Language

Physical activity has a positive impact on health and is therefore an important treatment element of orthopedic rehabilitation.
A rehabilitation stay is the ideal place to improve the health condition. As part of this study to increase physical activity, the rehabilitation facilities also offer the opportunity to participate in MoVo-LISA. The group program MoVo-LISA can help to significantly and sustainably increase physical activity. In combination, some participants receive an innovative smartphone-based intervention (MoVo app) that helps maintain physical activity after orthopedic rehabilitation. Research has shown that smartphone-based treatments can effectively increase and sustain physical activity.

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Brief Summary in Scientific Language

Interventions to increase and maintain physical activity are crucial in patients with musculoskeletal restrictions. The Motivation-Volition concept for promoting Lifestyle-Integrated Sport Activity (MoVo-LISA) can overcome the repeatedly reported low exercise adherence and effectively promote physical activity. However, there is a significant decrease in the absolute level of activity over time after the intervention (Fuchs et al., 2010; Fuchs et al., 2011; Gerber et al., Göhner et al., 2015; Krebs et al., 2015). Smartphone applications can be effectively and cost-effectively used to stabilize intervention effects (Fanning et al., 2012). Therefore, a smartphone app based on the MoVo concept (MoVo-App) was developed.
The aim of this study is to evaluate whether the MoVo-App in combination with the group-based MoVo intervention program (MoVo-LISA) during orthopedic rehabilitation can support people to maintain long-term physical activity.
In this randomized controlled trial (RCT) with parallel design, the two MoVo-LISA groups with (intervention group, IG) and without MoVo-App (control group, CG) are compared. The MoVo-App is introduced during inpatient orthopedic treatment as part of the MoVo-LISA small group program and has an intervention duration of 12 weeks. The IG enters their individual health goals, activity plans, behavioral barriers and counter strategies (barrier management) developed in MoVo-LISA into the MoVo-App. After rehabilitation, the MoVo-App offers a dairy for self-monitoring and a weekly reflection (extent of target achievement) in order to make corrections in the activity plans or barrier management. Both groups have unrestricted access to routine care.
200 previously minimally active participants are recruited during orthopedic inpatient rehabilitation. Assessments are carried out at admission and discharge of rehabilitation, 6 weeks and 3 (follow-up), 6 and 12 months after discharge (follow-up). The primary endpoint is the physical activity assessed by the Physical Activity, Exercise, and Sport Questionnaire (BSA-F; Fuchs et al., 2015). Secondary endpoints are cognitive mediators of behavioral change (e.g. self-efficacy or action planning), physical activity (IPAQ-sf; Craig et al., 2003), pain-related variables (e.g. pain intensity) as well as health-related quality of life. Demographic and medical variables, intervention adherence, and satisfaction are also assessed. The data is analyzed on an intention-to-treat basis with an additional per-protocol analysis.
In this study, the effectiveness of a smartphone app in combination with a face-to-face group intervention to promote physical activity is evaluated for the first time. The theoretical approach of the MoVo model can overcome the repeatedly reported problems in the implementation of changes in health behavior, e.g. physical activity, especially in patients with chronic illness or disability (Schwarzer et al., 2011). The innovative approach of using an app to promote sustainable physical activity, introduced within routine health care, will substantially increase access to such interventions.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Individual participant data are only available on request after de-identification beginning 12 months following article publication. Data will be made available to researchers who provide a methodologically sound proposal, not already covered by others. Proposals should be directed to the corresponding author. Data requestors will need to sign a data access agreement. Provision of data are subject to data security regulations.

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Organizational Data

  •   DRKS00014814
  •   2018/10/18
  •   [---]*
  •   yes
  •   Approved
  •   270/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   musculosceletal conditions
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Interventions/Observational Groups

  •   MoVo-LISA program: The Motivation-Volitions Concept for promoting Lifestyle-Integrated Sport Activity (MoVo-LISA) can overcome the commonly reported low exercise adherence and effectively promote physical activity. In the MoVo-LISA small group program, individual health goals, excercise plans, behavioural barriers and counter strategies (barrier management) are developed in two group and one individual sessions in the context of orthopedic rehabilitation.
  •   MoVo-LISA program + App: The MoVo app is introdused during inpatient orthopedic
    rehabiliation treatment and will be implemented within the MoVo-LISA Small Group Program and has a processing time of 12 weeks. Participants enter their individual health goals, excercise plans, behavioural barriers and counter strategies (barrier management) developed in MoVo-LISA into the MoVo-App. After rehabilitation, the MoVo-App performs a daily self-logging and a weekly reflection (extent of goal achievement) to enable corrections at the level of excercise plans or barrier management.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

physical activity, measured by the exercise and sports activity questionnaire (BSA-F, Fuchs et al., 2015). Assessments are performed at admission and discharge of rehabilitation, 6 weeks and 3 (post-treatment), 6 and 12 months after discharge (follow-up).

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Secondary Outcome

1. Movement activity, measured with the BSA, subscale movement activity (Fuchs et al., 2015)
Sport-related
2. self-efficacy
3. Goal intention
4. Self-Concordance (Seelig & Fuchs, 2006)
5. Barriers and Barriers Management (Krämer & Fuchs, 2010)
6. Consequence Experiences (Fuchs, 1994)
7. Action planning (Sniehotta et al., 2005)
8. Pain Intensity, Numeric Rating Scale (4 Items)
9. Pain Interference (BPI, Cleeland & Ryan, 1994)
10. Depression (PHQ-8, Kroenke et al., 2009)
11. Anxiety (GAD-7, Löwe et al., 2008)
12. Intervention satisfaction (adjusted items from the ZUF (Schmidt et al., 1989)
13. Intervention adherence (usage data of the app)
Assessments are performed at admission and discharge of rehabilitation, 6 weeks and 3 (post-treatment), 6 and 12 months after discharge (follow-up).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/01/10
  •   223
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Orthopedic diagnosis according to ICD-10
2. sufficient knowledge of the German language
3. own a smartphone
4. physically inactive (less than 30 min sports / week, in the last 3 months)
5. Internet and PC access for online assessments

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Exclusion Criteria

1. follow-up treatment (AHB)
2. Medically unsuitable

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Addresses

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    • SportpsychologieInstitut für Sport und SportwissenschaftAlbert-Ludwigs-Universität Freiburg
    • Mr.  Prof. Dr.  Reinhard  Fuchs 
    • Schwarzwaldstr. 175
    • 79117  Freiburg im Breisgau
    • Germany
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    • Sportpsychologie, Institut für Sport und Sportwissenschaft, Albert-Ludwigs-Universität Freiburg
    • Ms.  M.A.  Ramona  Wurst 
    • Schwarzwaldstr. 175
    • 79117  Freiburg im Breisgau
    • Germany
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    • Katholische Hochschule Freiburg
    • Ms.  Prof. Dr.  Wiebke  Göhner 
    • Karlstraße 63
    • 79104  Freiburg
    • Germany
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    • Schwarzwaldkliniken Bad Krozingen
    • Mr.  M.A.  Stephan  Kinkel 
    • Herbert-Hellmann-Allee 46
    • 79189  Bad Krozingen
    • Germany
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  • start of 1:1-Block address scientific-contact
    • SportpsychologieInstitut für Sport und SportwissenschaftAlbert-Ludwigs-Universität Freiburg
    • Ms.  Dr.  Sarah  Paganini 
    • Schwarzwaldstr. 175
    • 79117  Freiburg im Breisgau
    • Germany
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    • Sportpsychologie, Institut für Sport und Sportwissenschaft, Albert-Ludwigs-Universität Freiburg
    • Ms.  Dr.  Sarah  Paganini 
    • Schwarzwaldstr. 175
    • 79117  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • SportpsychologieInstitut für Sport und SportwissenschaftAlbert-Ludwigs-Universität Freiburg
    • Mr.  Prof. Dr.  Reinhard  Fuchs 
    • Schwarzwaldstr. 175
    • 79117  Freiburg im Breisgau
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.