Feasibility of a therapeutic exercise before total hip replacement

ISRCTN	ISRCTN09005050
DOI	https://doi.org/10.1186/ISRCTN09005050
Protocol serial number	N/A
Sponsor	Hospital Gelderse Vallei (Netherlands)
Funder	Hospital Gelderse Vallei (Netherlands)

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

Hospital Gelderse Vallei
Willy Brandtlaan 10
Ede
6716 RP
Netherlands

Email	VeldmanA@zgv.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled single-blind pilot trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	09/11/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan