Condition category
Musculoskeletal Diseases
Date applied
02/09/2009
Date assigned
26/10/2009
Last edited
26/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.zgv.nl

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

Publication citations

Additional files

Editorial Notes