No registrations found.
ID
Source
Brief title
Health condition
Elective surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the amount of daily physical activity during admission
and during the 2nd week after discharge measured with an activity monitor (the
Activ8) and a questionnaire about physical activity during hospitalization
(diary).
Secondary outcome
Secondary outcomes include quality of life (EQ5 -D, SF-36) and the demand of care in the 1st month after discharge.
Background summary
Background of the study:
There is increasing evidence for a beneficial effect of preoperative
conditioning of physical condition in patients undergoing surgery (BIBO, Better
In, Better Out). However, there is less attention to further optimize the
recovery during and after hospitalization, although it is known that physical
inactivity, even of short duration, can lead to significant decrease in
functional ability. The hospital physiotherapist has several interventions
available for physical activity during and immediately after hospitalization to
promote, but a systematic selection and evaluation are lacking.
Objective of the study:
Determine the feasibility of a study on the effectiveness of an integrated
physiotherapy strategy aimed at promoting healthy physical activity during and
after hospitalization. If the pilot project proves to be feasible, a
multicenter randomized controlled trial (RCT) set .
Study design:
This is a pilot pre/post design on two surgical wards at the LUMC. The
strategy consists of : 1) electronic or paper information about physical
activity around the hospitalization ; 2 ) twice daily exercise program through
a movie (hospital television , laptop, tablet ) ; 3 ) communication with icons
around the bed of the patient to improve communication around the functional
mobility of the patient; 4 ) pedometer to monitor their own physical activity;
5 ) tailored physiotherapy: a physical coach ( email and phone) during
hospitalization and shortly after discharge; 6) individual exercise through a
digital training program and an App for patients ( Physitrack ) which gradually
adds daily exercises and activities.
The control group consists of usual care.
Study population:
Sixty adult patients from two surgical wards undergoing elective surgical
intervention, with a planned hospital stay of 3 days or more, will be enrolled.
Thirty patients will be given the intervention and 30 patients forming the
control group wille receive the usual care .
Primary study parameters/outcome of the study:
Effect
The primary outcome is the amount of daily physical activity during admission
and during the 2nd week after discharge measured with an activity monitor (the
Activ8) and a questionnaire about physical activity during hospitalization
(diary).
Feasibility
The evaluation process also involves percentage of patients meeting inclusion
criteria and participates in the study, the compliance (adherence) with the
different components of the intervention, and the percentage of patients >
completes 80% of the measurements. In addition, care providers and patients
registered with the intervention are evaluated on their the experiences
(questionnaires) .
Secondary study parameters/outcome of the study (if applicable):
Secondary outcomes include quality of life (EQ5 -D, SF-36) and the demand of
care in the 1st month after discharge.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Patients taking part in the study fill in three questionnaires about their
physical activity and quality of life (times: for hospitalization, at discharge
and 4 weeks after discharge). During hospitalization and during the 2nd week
after discharge they carry an activity monitor for 7 days. Patients who are
being included in the period in which the strategy is implemented get the
intervention in addition to the regular physiotherapy. The intervention focuses
on structured restarting physical activities and offering therapy through
innovative methods.
Study objective
Patients in the intervention group are more physically actice during and the 2nd week after hospitalisation.
Study design
Fill in three questionnaires about their physical activity and quality of life (times: for hospitalization, at discharge and 4 weeks after discharge). During hospitalization and during the 2nd week after discharge they carry an activity monitor for 7 days.
Intervention
The strategy consists of : 1) electronic or paper information about physical
activity around the hospitalization ; 2 ) twice daily exercise program through
a movie (hospital television , laptop, tablet ) ; 3 ) communication with icons
around the bed of the patient to improve communication around the functional
mobility of the patient; 4 ) pedometer to monitor their own physical activity;
5 ) tailored physiotherapy: a physical coach ( email and phone) during
hospitalization and shortly after discharge; 6) individual exercise through a
digital training program and an App for patients ( Physitrack ) which gradually
adds daily exercises and activities.
The control group consists of usual care.
Inclusion criteria
-18 years and older
-Living self-dependent
-Scheduled surgery
Exclusion criteria
-Insufficient knowledge of the Dutch language to be able to fill in a questionnaire and to understand the information strategy (Dutch movie, Dutch app and Dutch information).
-Not able to wear or control an activity monitor during 7 days and to return this by postal mail.
-Visual or hearing problems that make it impossible to use the movie and the app properly.
-Postoperative conditions preventing participation the strategy or completing the assessments.
-Cognitive problems that prevent participation the strategy or completing the assessments.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL7820 |
Other | METC LUMC : P15.026 (CCMO-number NL52321.058.15) |