Contact information
Type
Scientific
Primary contact
Dr Nico van Meeteren
ORCID ID
Contact details
Hospital Gelderse Vallei
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
VeldmanA@zgv.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Feasibility and preliminary effectiveness of a short-term, preoperative therapeutic exercise programme for frail, elderly patients awaiting total hip replacement
Acronym
Profyt2
Study hypothesis
Is a short-term preoperative therapeutic intervention for frail elderly patients with osteoarthritis awaiting total hip replacement feasible?
Ethics approval
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.
Study design
Randomised controlled single-blind pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
05/06/2007
Overall trial end date
09/11/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Unable to understand Dutch
2. Patients with severe heart disease
Recruitment start date
05/06/2007
Recruitment end date
09/11/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Hospital Gelderse Vallei
Ede
6716 RP
Netherlands
Sponsor information
Organisation
Hospital Gelderse Vallei (Netherlands)
Sponsor details
Willy Brandtlaan 10
Ede
6716 RP
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Gelderse Vallei (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary