Feasibility of a therapeutic exercise before total hip replacement
| ISRCTN | ISRCTN09005050 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09005050 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/09/2009
- Registration date
- 26/10/2009
- Last edited
- 26/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nico van Meeteren
Scientific
Scientific
Hospital Gelderse Vallei
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
| VeldmanA@zgv.nl |
Study information
| Study design | Randomised controlled single-blind pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Feasibility and preliminary effectiveness of a short-term, preoperative therapeutic exercise programme for frail, elderly patients awaiting total hip replacement |
| Study acronym | Profyt2 |
| Study objectives | Is a short-term preoperative therapeutic intervention for frail elderly patients with osteoarthritis awaiting total hip replacement feasible? |
| Ethics approval(s) | Institutional Review Board of the University Medical Centre Utrecht (protocol number 07/051) and the Gelderse Vallei Hospital (protocol number Profyt 06/184-O) approved this study on the 5th June 2007. |
| Health condition(s) or problem(s) studied | Hip osteoarthritis |
| Intervention | Experimental group: Short-term (3-6 weeks), intensive, tailor-made therapeutic exercise (twice a week). Usual care group: One information meeting and practicing the use of crutches. |
| Intervention type | Other |
| Primary outcome measure | Feasibility towards patients satisfactory is assessed by the following main outcomes: 1. The occurrence of adverse effects during testing or training. Participants will have to register any discomforted, stiffness or other adverse events in their diary. 2. Adherence to the treatment. Both groups are asked to register their adherence to the home based training programme (i.e. time exercised, days exercised and perceived exertion). Pedometer adherence is defined as the number of steps recorded on the daily pedometer log that met or surpassed the weekly goal. Also adequate use of the diary will be assessed as part of the adherence to the intervention. 3. The patients' appreciation and motivation towards the therapeutic intervention will be determined by a patient evaluation form (satisfaction questionnaire) that patients complete at the end of the preoperative training. |
| Secondary outcome measures | 1. Preoperative effectiveness: 1.1. Aerobic capacity, assessed with the Physical Working Capacity 170 1.2. Strength and power of the lower limb muscles is assessed by the chair rise time 1.3. Functional mobility is assessed with the Timed Up and Go Test 1.4. Walking capacity is assessed with the six minutes walk test (6MWT) 1.5. Pain, functioning and quality of life is assessed with the Hip disability and Osteoarthritis Outcome Score (HOOS) 1.6. Patient specific complaint (Patient Specifieke Klacht [PSK]) questionnaire 1.7. Functional activities are assessed by the Longitudinal Aging Study Amsterdam (LASA) Physical Activity Questionnaire (LAPAQ) 2. Postoperative effectiveness: 2.1. Length of stay 2.2. Discharge destination (home, rehabilitation centre or nursing home) 2.3. The patient's functional mobility score using the Iowa Level of Assistance Scale |
| Overall study start date | 05/06/2007 |
| Completion date | 09/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Both males and females, age ≥70 years 2. Scheduled for elective total hip arthroplasty (THA) (minimum waiting period of 3 weeks) 3. Osteoarthritis is the motive for the THA 4. First surgical intervention of this pathology 5. Scores ≥2 on the Clinical Frailty Scale (CFS) 6. Able to permit time for the intervention between enrolment and surgery |
| Key exclusion criteria | 1. Unable to understand Dutch 2. Patients with severe heart disease |
| Date of first enrolment | 05/06/2007 |
| Date of final enrolment | 09/11/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hospital Gelderse Vallei
Ede
6716 RP
Netherlands
6716 RP
Netherlands
Sponsor information
Hospital Gelderse Vallei (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
| Website | http://www.zgv.nl |
|---|---|
"ROR" |
https://ror.org/03862t386 |
Funders
Funder type
Hospital/treatment centre
Hospital Gelderse Vallei (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
