The objective of this study is to evaluate the feasibility and to determine the preliminary effects on physical functioning, muscle function, body composition and postoperative recovery of a combined preoperative nutrition and exercise intervention…
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Health condition
sarcopene obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility is assessed by adherence to treatment, inclusion rates, drop out
rates and adverse events and complications.
The amount of attended training sessions attended and the achieved intensity
are noted. The physical activity (accelerometer) and food intake (food diary)
are also measured.
The appreciation and motivation of the patient will be assessed with
questionnaires.
Secondary outcome
Effectiveness is assessed by measuring physical functioning (timed up and go
test, hand grip strength, walking speed/ six-minute walk test, chair rise time
test, questionnaires), body composition (BIA/ DEXA) and inflammation (IL-6),
before and after 6 weeks of intervention.
In addition, postoperative inpatient complications, CRP, recovery of physical
functioning and length of hospital stay will be assessed.
Furthermore, nutritional intake (3-day food diary) and physical activity (by
accelerometer) will be measured.
Background summary
The incidence of patients with sarcopenic obesity (SO) in orthopedic surgery is
growing, with a reported prevalence of 3 up to 35%. The poor skeletal muscle
function, decreased physical func-tioning and increased inflammation associated
with SO gives an additional risk of postoperative complications. The
combination of exercise and dietary intervention seems the best strategy to
counteract SO. However, studies investigating the effect of a combined approach
as a preoperative intervention in patients with SO have not been conducted yet.
Therefore, we aim to evaluate, both in terms of feasibility and effectiveness,
a combined preoperative nutrition and exercise intervention in patients who
receive a total hip or knee arthroplasty (THA/TKA).
Study objective
The objective of this study is to evaluate the feasibility and to determine the
preliminary effects on physical functioning, muscle function, body composition
and postoperative recovery of a combined preoperative nutrition and exercise
intervention in patients with sarcopenic obesity who receive a total hip or
knee arthroplasty.
Study design
A pilot randomized controlled trial (RCT)
Intervention
The intervention group will follow a supervised (by a physiotherapist) exercise
intervention of 6 weeks (twice a week) with progressive strength training and
aerobic training. This will be combined with a nutritional intervention (by a
dietician) focusing on optimal protein intake, i.e. 1.2 g / kg of adjusted body
weight per day divided over the day. The dietary intervention will consist of a
comprehensive screening, determining intake, and nutritional advice during 3
repeat consultations.
Usual care (control) group: Patients receive general exercise advice, a
referral for *standard* physiotherapy and dietary guidelines only in case of
malnutrition. Furthermore, in the online program eZorg, patients can find
information on the Dutch dietary guidelines and what they can do to make their
food habits healthier.
Study burden and risks
• The patients in the both groups will be extensively examined pre-intervention
(6 weeks before surgery) and post-intervention (about 2 days before surgery).
This will take about 1,5 hours for each session. Postoperative examination is
usual care (or data from patient files) and does not require extra visits to
the hospital. Patients* appreciation and motivation will be investigated using
a questionnaire based on a 10-point Likert scale.
• Taking blood samples will be done three times in both groups.
Pre-intervention (usual care), post-intervention (2 days before surgery,
additional moment) and 1 day after surgery (usual care).
• A DEXA scan and BIA measurement will be done twice preoperatively (six weeks
and two days before surgery). DEXA is a simple, quick and noninvasive
procedure. The amount of radiation used is extremely small*less than one-tenth
the dose of a standard chest x-ray. No radiation remains in a patient's body
after an x-ray examination.
• The intervention group will receive a supervised training (in the hospital or
a physical therapy practice within out network in their home town) twice a week
60 minutes. Furthermore, they will have three sessions (30 minutes each) with a
dietician to optimize their protein consumption to 1.2g/kg adjusted body weight
and fill in three times a three-day food diary. Two of these sessions will be
combined with measurements at T0 and T2 and one session can be done by phone.
No extra supplements or compulsory food should be taken.
• Patients in both groups will be stimulated to be physically active at least
150 minutes per week. They will be asked to wear an accelerometer to check
their adherence with this advice.
• The nature of effort is that the exercise program gives physical exertion
(functional, strength and aerobic testing and training). Osteoarthritis,
obesity or frailty are not contra indications to exercise. The therapeutic
intervention will be tailored to each individual, based on guidelines and take
into account limitations such as pain, comorbidity or obesity. The
anesthesiologist will perform a medical clearance and exercises will be given
by experienced physical ther-apists.
• The nutritional advice will be tailored to each individual, based on national
guidelines and the experienced dietician will take into account specific needs
or contraindications for the dietary advice (as usual) so therefore there are
no additional risks.
Laarweg 35 10
Ede 6721 DB
NL
Laarweg 35 10
Ede 6721 DB
NL
Listed location countries
Age
Inclusion criteria
• Scheduled for THA or TKA with a waiting period of minimal 6 weeks (which is
the usual waiting period)
• Osteoarthritis as reason for surgery
• Having obesity (BMI >=30 kg/m2)
• Having muscle weakness (Men: Hand Grip Strength (HGS) <27kg; Women: HGS <16kg
or Chair stand >15sec for five rises)
• Adequate cognitive functioning (the patient is capable to understand
instructions and to per-form the screening)
• Age 18 years or older
Exclusion criteria
Patient
• unable to understand Dutch;
• diagnosed with dementia;
• who are unable to exercise due to comorbidities/ contra-indications. Absolute
contra-indications for exercise are listed in the Dutch guideline for
osteoarthritis and in the ACSM's Guidelines for Exercise Testing and
Prescription;
• with severe renal insufficiency or an eGFR<30 (estimated Glomerular
Filtration Rate)
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 | NL72249.081.19 |