Movement Coaching: implementation in inpatient rehabilitation combined with post-rehabilitation support and evaluation (RCT) of effects on physical activity and participation.
Organizational Data
- DRKS-ID:
- DRKS00004878
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2013-04-16
- Last update in DRKS:
- 2016-05-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
BeCo
URL of the study
Brief summary in lay language
Lack of physical activity and sedentary lifestyle are associated highly with musculoscletal disorders. Exercise therapy is an essential component of inpatient rehabilitation of low back pain. Nevertheless only a few patients do integrate health enhancing physical activity and/or sport activity in their lifestyle. The implementation of movement coaching in inpatient rehabilitation combined with post-rehabilitation coaching support (telephone, online platform) seeks to improve health enhancing physical activity and participation of low back pain patients after inpatient rehabilitation. Results are compared with a control group without movement coaching.
Brief summary in scientific language
Lack of physical activity and sedentary lifestyle are associated highly with musculoscletal disorders. Improvement of health enhancing physical activity behavior is an essential aim of inpatient rehabilitation and aftercare. Aim of the study is to raise physical activity of patients with low back pain. Therefore movement coaching is implemented in inpatient rehabilitation and aftercare. The movement coaching intervention consists of group intervention (during inpatient rehabilitation) combined with telephone and online support (aftercare). In a randomized controlled trail patients with low back pain are evaluated at three measurement points (T1: start of inpatient rehabilitation, T2: 6 months after inpatient rehabilitation, T3: twelve months after inpatient rehabilitation). Intervention group (IG) receives two times movement coaching during inpatient rehabilitation and movement coaching via telephone and internet until 6 months after rehabilitation. Additionally IG can use an interactive online platform until 12 months after inpatient rehabilitation (moodle, web 2.0). Control Group (CG) receives two lectures on health enhancing physical activity during inpatient rehabilitation and can download information concerning the lectures afterwards. Physical activity behavior is measured at three measuring points by questionnaire. Additionally physical activity patterns of 20 subjects of each group are measured by accelerometer. Participation and subjective employment prognosis of the patient are measured at each of the three measuring points.
Health condition or problem studied
- ICD10:
- M54 - Dorsalgia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervention group (IG) receives two times movement coaching during inpatient rehabilitation and movement coaching via telephone and internet until 6 months after rehabilitation. Additionally IG can use an interactive online platform until 12 months after inpatient rehabilitation (moodle, web 2.0). Maximum group size of the IG during inpatient rehabilitation is 6 persons and duration 60 minutes each. Post-rehabilitation movement coaching takes part at least two times by telephone (3rd and 12. week after inpatient rehabilitation). As circumstances require further coaching contacts are possible. Patients can contact the movement coach themselves by telephone or internet. Additionally patients of the IG receive further information and can communicate with the coach or other patients on an online platform.
- Arm 2:
- Control Group (CG) receives two lectures on health enhancing physical activity during inpatient rehabilitation and can download information concerning the lectures afterwards. There is no communication between coach and patient after inpatient rehabilitation.
Endpoints
- Primary outcome:
- Physical activity (total, transport, leasure-time) measured by questionnaire (GPAQ) and accelerometer (randomized subgroup). Evaluation of IG compared to CG six (T2) and twelve (T3) months after inpatient rehabilitation.
- Secondary outcome:
- Participation (IMET), subjective employment prognosis (SPE-Skala): evaluation of IG compared to CG six (T2) and twelve (T3) months after inpatient rehabilitation.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Aggertalklinik Engelskirchen
Recruitment period and number of participants
- Planned study start date:
- 2013-05-02
- Actual study start date:
- 2013-05-02
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-05-17
- Target Sample Size:
- 400
- Final Sample Size:
- 412
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- - inpatient-rehabilitation because of chronic low back pain - signed declaration of agreement
Exclusion Criteria
age over 65; no declaration of interest; surgery before rehabilitation (3 months)
Addresses
Primary Sponsor
- Address:
- Deutsche Rentenversicherung Rheinland, Abt. betriebswirtschaftliche Steuerung40194 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Deutsche Sporthochschule KölnDr. Andrea SchallerAm Sportpark Müngersdorf50933 KölnGermany
- Telephone:
- 0221-4982-7112
- Fax:
- 0221-4982-8390
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dshs-koeln.de
Contact for Public Queries
- Address:
- Deutsche Sporthochschule KölnDr. Andrea SchallerAm Sportpark Müngersdorf50933 KölnGermany
- Telephone:
- 0221-4982-7112
- Fax:
- 0221-4982-8390
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dshs-koeln.de
Principal Investigator
- Address:
- Deutsche Sporthochschule KölnDr. Andrea SchallerAm Sportpark Müngersdorf50933 KölnGermany
- Telephone:
- 0221-4982-7112
- Fax:
- 0221-4982-8390
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dshs-koeln.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche Rentenversicherung Rheinland, Abt. betriebswirtschaftliche Steuerung40194 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Deutschen Sporthochschule KölnAm Sportpark Müngersdorf 650933 KölnGermany
- Telephone:
- (+49)221-49823810
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-10-04
- Ethics committee number:
- 56/12
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-10-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry