Impact of a tailored activity counselling intervention during inpatient rehabilitation after knee and hip arthroplasty
Organizational Data
- DRKS-ID:
- DRKS00012682
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-08-04
- Last update in DRKS:
- 2017-08-04
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Reha-OL
URL of the study
No Entry
Brief summary in lay language
The purpose of the study is to analyse if an additional promotion of physical activity, such as daily steps, during inpatient rehabilitation, leads to a longer lasting increase of the physical activity up to six months after rehabilitation. Recent studies indicated that the physical activity of patients after receiving their first knee or hip arthroplasty is lower compared to healthy people. Thus, the physical activity is addressed during inpatient rehabilitation with a step counter, measuring the daily steps taken. The data is discussed twice a week with the patients, and the aim is to increase the daily steps by 5% twice a week. Patients are included when 45 years or older, receiving their first knee or hip joint due to osteoarthritis. One group of patients receives the step counter (intervention group), a second group does not (control group). It is analysed if the patients of the intervention group is more active three and six months after inpatient rehabilitation compared to the control group.
Brief summary in scientific language
Own research demonstrates that physical activity after primary knee or hip joint replacement is lower compared to healthy peers, and increased very slowly after end of treatment (Brandes et al., 2011). Comorbidities further decelerate the restoration of physical activity (Harding et al., 2013; Peiris et al., 2013; Tsonga et al., 2011). Hence, four years after surgery patients walk considerably less than healthy peers (Vissers et al., 2013). Recently, step counting has proven to be a suitable intervention to increase daily physical activity in various settings. In particular, adaptive approaches such as increasing physical activity by 10%, thus taking the current daily activity into account, seem to be promosing instead of using rigid recommendation, such as walking 10.000 steps/day, and were sucessfully implemented for weight reduction (Adams et al., 2013) and cardiologic rehabilitation (Kaminsky et al., 2013). However, a direct transfer of previous findings is not applicable due to the relatively small duration of inpatient rehabilitation of knee/hip joint athroplasty patients, which is three weeks in Germany.
Health condition or problem studied
- ICD10:
- Z96.64
- ICD10:
- Z96.65
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Control group. The controls received the standard rehabilitation procedures only, such as strength training, aqua therapy, courses with respect to activities of daily life.
- Arm 2:
- Intervention group. The intervention group received the standard procedures of the rehabilitation (see control group) and, additionally, a step counter for the time of the inpatient rehabilitation. The step counter was read out twice a week by an employee of the rehabilitation centre. The data was visualized to the patient by a plot steps by minute for every day. Periods of continuous walking were identified. Subsequently, the patient was encouraged to increase the activity by 5% until the next meeting with the employee. No rewards for reaching the goal as well as no penalties for not meeting the goal were provided.
Endpoints
- Primary outcome:
- Average number of steps per day, measured over a period of seven days, six months after finishing inpatient rehabilitation. Daily steps were measured by the Step Activity Monitor 3.0 (Orthocare Innovations, USA).
- Secondary outcome:
- Clinical outcome: Oxford knee/hip score Quality of life: SF-36. Measured six months after finishing the inpatient rehabilitation.
Study Design
- Purpose:
- Prevention
- 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:
- No
- Assignment:
- Parallel
- 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 Rehabilitationszentrum Oldenburg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2014-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2016-07-15
- Target Sample Size:
- 80
- Final Sample Size:
- 65
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 40 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Primary, unilateral knee or hip arthroplasty, due to osteoarthritis
Exclusion Criteria
contralateral arthroplasty, contralateral end-stage osteoarthritis, secondary arthroplasty
Addresses
Primary Sponsor
- Address:
- Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPSPD Dr. Mirko BrandesAchterstraße 3028359 BremenGermany
- Telephone:
- 0421 218 56905
- 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:
- Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPSPD Dr. Mirko BrandesAchterstraße 3028359 BremenGermany
- Telephone:
- 0421 218 56905
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bips.eu
Contact for Public Queries
- Address:
- Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPSPD Dr. Mirko BrandesAchterstraße 3028359 BremenGermany
- Telephone:
- 0421 218 56905
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPSPD Dr. Mirko BrandesAchterstraße 3028359 BremenGermany
- Telephone:
- 0421 218 56905
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bips.eu
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPSAchterstraße 3028359 BremenGermany
- Telephone:
- 0421 218 56905
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Geschäftsstelle der medizinischen Ethikkommission, Fakultät VI Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg, Gebäude V04 (Raum 1-137)Ammerländer Heerstraße 14026129 OldenburgGermany
- Telephone:
- +49-441-7983109
- 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:
- 2014-02-19
- Ethics committee number:
- 11/2014
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-03-03
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