How Shoulder Immobilization Influences Daily Physical Activity – An Accelerometer Based Study
Organizational Data
- DRKS-ID:
- DRKS00017636
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-09-13
- Last update in DRKS:
- 2019-09-13
- Registration type:
- Retrospective
Acronym/abbreviation of the study
AWTS
URL of the study
No Entry
Brief summary in lay language
Regular physical activity is a clearly proven health resource in prevention and rehabilitation. Physical activity can help prevent cardiovascular disease, diabetes II and obesity as well as numerous other physical and mental disorders. After operations, the rehabilitation phase is used to prevent chronic and degenerative diseases and to speed up the healing process. The immobilization of the shoulder joint is a necessary component in the postoperative treatment following shoulder injuries or reconstructive operative interventions in case of shoulder conditions caused by degenerative diseases. Physical activity in this context is thus potentially very significant for elderly patients. The aim of this study is thus to measure daily activity in the case of an immobilized shoulder joint in order to derive a transfer to the postoperative therapy program following shoulder operations and to expand possible recommendations for rehabilitation therapy. 21 healthy volunteers were immobilized in an orthosis (DJO Ultrasling III) for 10 hours on two consecutive days. In the following week, activity was measured on the same days without the orthosis. Activity was measured by accelerometer based step count StepWatchTMActivity Monitor (SAM). A questionnaire was administered to evaluate subjective activity.
Brief summary in scientific language
Purpose The harmful effect of sedentary behavior does not receive much attention in orthopedic surgery even though immobilization, especially of the lower extremity, has been associated with reduced physical activity. Immobilization of the shoulder is common after reconstructive shoulder surgery and could also potentially lead to reduced physical activity and have a negative effect on a patient’s general health. Methods 21 healthy volunteers were immobilized in an orthosis (DJO Ultrasling III) for 10 hours on two consecutive days. In the following week, activity was measured on the same days without the orthosis. Activity was measured by accelerometer based step count StepWatchTMActivity Monitor (SAM). Average age was 26 +/-3 years. A questionnaire was administered to evaluate subjective activity.
Health condition or problem studied
- Free text:
- healthy volunteers
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- 21 healthy volunteers were immobilized in an orthosis. In the following week, activity was measured on the same days without the orthosis. Activity was measured by accelerometer based step count StepWatchTMActivity Monitor (SAM). Therefore Interventional Group is his own control Group.
Endpoints
- Primary outcome:
- Measurement was carried out on two consecutive days for 10 hours. First measurement took place with immobilized shoulder in an orthosis. In the following week, activity was measured on the same days without the orthosis. Activity was measured by accelerometer based step count StepWatchTMActivity Monitor (SAM). A questionnaire was administered to evaluate subjective activity at both times of activity measurement.
- Secondary outcome:
- none
Study Design
- Purpose:
- Treatment
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
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):
-
- Other Institut für Sportmedizin Münster
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2018-06-03
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-10-28
- Target Sample Size:
- 21
- Final Sample Size:
- 21
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 30 Years
- Additional Inclusion Criteria:
- Inclusion criteria: Between 18 and 30 years of age signed an informed consent form.
Exclusion Criteria
Exclusion criteria: Acute or chronic diseases of the cardiovascular system or the passive / active musculoskeletal system.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Münster OrthopädieDr. med. Carolin RickertAlbert Schweitzer Campus 148149 MünsterGermany
- Telephone:
- 0251 83 47980
- Fax:
- 0251 8347903
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukm.de/index.php?id=orthopaedie_uebersicht
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Münster OrthopädieDr. med. Carolin RickertAlbert Schweitzer Campus 148149 MünsterGermany
- Telephone:
- 0251 83 47980
- Fax:
- 0251 8347903
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukm.de/index.php?id=orthopaedie_uebersicht
Contact for Public Queries
- Address:
- Universitätsklinikum Münster OrthopädieDr. med. Carolin RickertAlbert Schweitzer Campus 148149 MünsterGermany
- Telephone:
- 0251 83 47980
- Fax:
- 0251 8347903
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukm.de/index.php?id=orthopaedie_uebersicht
Principal Investigator
- Address:
- Universitätsklinikum Münster OrthopädieDr. med. Carolin RickertAlbert Schweitzer Campus 148149 MünsterGermany
- Telephone:
- 0251 83 47980
- Fax:
- 0251 8347903
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukm.de/index.php?id=orthopaedie_uebersicht
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Münster OrthopädieAlbert Schweitzer Campus 148149 MünsterGermany
- Telephone:
- 0251 83 47980
- Fax:
- 0251 8347903
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukm.de/index.php?id=orthopaedie_uebersicht
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität MünsterGartenstraße 210-21448147 MünsterGermany
- Telephone:
- +49-251-9292460
- Fax:
- +49-251-9292478
- 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:
- 2018-02-03
- Ethics committee number:
- 2018-290-f-S
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-04-29
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