The objective of this pilot study is to investigate the feasibility and effect of a high-intensity physical training program for elderly patients who are scheduled for abdominal oncological surgery on the preoperative maximal aerobic capacity and…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximal aerobic capacity (VO2max)
Strength lower leg extensors and inspiratory muscles.
Patients satisfaction with and adherence to the training.
Secondary outcome
Hand grip strength
Maximal Inspiratory Pressure (MIP)
Endurance inspiratory muscles
Self reported activities (LAPAQ)
Functional mobility (time to go up and go)
Walking time (pedometer)
Quality of live (EORTC QLQ-C30 questionnaire)
Background summary
Peri-operative care is extending to the preoperative period. The underlying
notion is: the better patients enter the hospital, the better they will leave.
Functional capacity forms part of the preoperative risk profile, predicting the
postoperative course. Especially elderly patients* lack of functional capacity
can lead to a postoperative functional decline causing postoperative
complications and an increase of length of stay. Within the preoperative
framework, maximal aerobic capacity and muscle strength of the inspiratory and
lower leg muscles are important determinants of functional capacity.
Preoperative training of patients who are scheduled for elective oncological
surgery can improve these determinants prior to surgery. There is evidence that
long-term training of the elderly has a positive effect on maximal aerobic
capacity and muscle strength. However, the effect of a high-intensity training
of 2-4 weeks (length of time on the waiting list) needs further investigation.
Study objective
The objective of this pilot study is to investigate the feasibility and effect
of a high-intensity physical training program for elderly patients who are
scheduled for abdominal oncological surgery on the preoperative maximal aerobic
capacity and muscle strength.
Study design
A single blind randomized controlled trial.
Intervention
The intervention consists of a preoperative patient-tailored physical training
program to improve the functional capacity. The control group receives a home
based exercise program. The intervention group receives an additional
high-intensity training program, three times a week in the outpatient
department of the hospital. The training is directed at improving the exercise
capacity, the function of the inspiratory muscles and the muscle strength of
the lower limb muscles.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness
Time investment for the patients
- screening at the onset of the study and 2 days before surgery, 60 minutes
each time (intervention and control group)
- training 2 - 3 times a week during 60 minutes for 2-4 weeks in the outpatient
department of the hospital (intervention group)
- training at home on the days the patients don*t train in the outpatient
department of the hospital for 30 minutes each day (intervention group)
- training at home for 30 minutes each day (control group)
Nature of burden
- high intensity physical exertion (intervention group).
- physical exertion (control group).
- completing a questionnaire (intervention and control group).
- performance of a simple functional test in postoperative period (30 seconds,
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.
Heidelberglaan 100
3584CX Utrecht
Nederland
Heidelberglaan 100
3584CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
1. Elective colon surgery (waiting period for a minimum of 2 weeks)
2. Age 60 >= years
3. Adequate cognitive functioning
Exclusion criteria
1. Heart disease that prohibit or impede exercise
2. Severe systemic illness
3. Recent embolism
4. Thrombophlebitis
5. Uncontrolled diabetes
6. Severe orthopedic conditions that prohibit or impede exercise
7. Dependent on a wheelchair
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 | NL13239.041.06 |