Primary Objective: The primary objective is to investigate the feasibility of a short-term preoperative physical therapeutic intervention for frail elderly patients, who have a higher risk on postoperative complications or a delayed recovery, after…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility is the main study parameter in this study. Patients satisfaction
with and adherence to the training will be assessed and also occurrence of
adverse events will be monitored. Also the patients satisfaction towards the
questionnaires and physical tests is assessed.
Secondary outcome
- Aerobe Capacity (PWC-170)
- Muscle strength of the lower limbs (1-RM/Chair Rise Time)
- Pain and function of the hip joint (HOOS)
- Quality of Life (SF-36)
- Functional mobility (Timed Up and Go)
- Patient Specifieke Klachten (PSK)
- Self reported activities (LAPAQ and Pedometer)
- Functional mobility (time to go up and go)
- Walking capacity (six minute walk test)
Background summary
Total hip arthroplasty (THA) as final treatment in end-stage osteoarthritis has
become more and more accepted and used over the last two decades. Though most
patients recover significantly after a THA, others experience fewer benefits.
Often, the persons that benefit the most from THA are in general preoperative
in a better functional status than those who benefit less. Numerous
preoperative factors, such as negative expectations, functional status and pain
can negatively affect the outcome of a THA.
It seems rational, that improving the preoperative functional status would also
improve the outcome of the THA. The underlying notion is: *the better patients
enter the hospital, the better they will leave*. Therefore, we hypothesize that
therapeutic training of the aerobic capacity, muscle strength and functional
capacity will lead to a faster hospital admission after the total hip
arthroplasty. To gain more insight on the effects of a therapeutic intervention
on the postoperative recovery in frail elderly patients who were scheduled for
elective THA, a full randomized controlled trial (RCT) has to be performed. But
before embarking on a proper RCT, we will first perform a pilot study to test
the feasibility of the approach and to help clarify decisions about operational
issues and procedures.
Study objective
Primary Objective:
The primary objective is to investigate the feasibility of a short-term
preoperative physical therapeutic intervention for frail elderly patients, who
have a higher risk on postoperative complications or a delayed recovery, after
elective total hip arthroplasty.
Secondary Objective(s):
The secondary objectives are to investigate the effect of short-term
high-intensity physical training program for frail elderly patients who are
scheduled for elective total hip arthroplasty on (i) the preoperative aerobic
and functional capacity and muscle strength and (ii) on the postoperative
health status and the functional recovery.
Study design
Single blind randomized controlled pilot trial.
Intervention
The intervention group receives a preoperative patient-tailored therapeutic
physical exercise program for 3-6 weeks, 2-3 times a week. The patients recieve
a home-based exerciseprogram for minimal 30 minutes on non-trainingdays. The
training is directed at improving the aerobic capacity, the muscle strength of
the lower limb muscles and the functional capacity.
Study burden and risks
Time investment for the patients
- screening at the onset of the study and 2 days before surgery, 90 minutes
each time (intervention and control group)
- training 2-3 times a week during 60 minutes for 3-6 weeks in the outpatient
department of the hospital
- training at home for minimal 30 minutes each day, on the days the patients do
not train at the hospital (intervention group)
Nature of burden
- high intensity physical exertion (intervention group).
- completing a questionnaire (intervention and control group).
- performance of a simple functional test in postoperative period (intervention
and control group).
Risks
Elderly patients can safely tolerate high-intensity resistance training
programs. The risk is comparable with the normal risk associated with physical
exertion.
Willy Brandtlaan 10
6716 RP Ede
Nederland
Willy Brandtlaan 10
6716 RP Ede
Nederland
Listed location countries
Age
Inclusion criteria
a. Scheduled for elective total hip arthroplasty (minimum waiting period of 3 weeks)
b. Osteoarthritis is the motive for the THA.
c. First surgical intervention of this pathology.
d. High risk for postoperative functional decline.
e. Age >= 70 years.
Exclusion criteria
a. Unable to understand Dutch
b. Severe heartdisease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL15874.041.07 |