The primary aim of this pilot-study is to determine the sensitivity of a new ambulatory method for measuring differences in mobility between before and after an intervention program. A secondary objective is to determine the conditions for using theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
het betreft gezonde ouderen met een enigszins verminderde balans
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is power, measured with a new ambulatory
measurement system. Power is measured in the home-situation and in a
standardized situation with hybrid sensors.
Secondary outcome
Score on three questionnaires: Groningen Frailty Indicator (GFI), Falls
Efficacy Scale (FES), Groningen Activiteiten RestrictieSchaal (GARS)
Score on clinical tests: Timed Up & Go (TUG), Berg*s Balance Scale (BBS), force
generating capacity of hip, knee and ankle extensors and flexors, measured with
a Hand Held Dynamometer.
Background summary
With the increasing number of elderly in Europe the number of falls increases.
A fall-accident commonly leads to loss of independency in elderly. Mobility,
lower extremity muscle function and balance are determining factors for risk of
falling. To prevent elderly from falling it is necessary to detect changes in
these determining factors in an early stage. If an increased fall-risk is
detected participation in an exercise program can be considered.
Until now there is no clinical measurement method to detect deteriorating
mobility, muscle function and balance in the home-situation. Newly developed
ambulatory measurement systems are able to measure movement patterns in daily
life, from which changes in the mentioned factors can be extracted.
Study objective
The primary aim of this pilot-study is to determine the sensitivity of a new
ambulatory method for measuring differences in mobility between before and
after an intervention program. A secondary objective is to determine the
conditions for using the new method for monitoring elderly. Another secondary
objective is to determine the minimum number of subjects that need to be
included to be able to measure intervention-effects with ambulatory measurement
systems in future research.
Study design
This pilot study is an intervention study with two moments of measurement. Part
of the participants participate in an intervention program offered by the
researcher. The other part of the participants participate in an intervention
program offered by a physiotherapist or MBVO. Both programs are similar with
regard to content of the program, intensity and duration. The reason for this
twofold method is that in this way we will be able to include the aimed number
of participants. Afterward the collected data will be pooled. There is no
control group, because the subject of research is the measurement method and
not the intervention itself.
Intervention
Part of the participants participate in an intervention program offered by the
researcher. The other participants participate in an intervention program
offered by a physiotherapist or MBVO. Both programs are similar with regard to
content of the program, intensity and duration. The exercise programs exists of
exercises for improving balance, power and force generating capacity of the
lower extremities. All subjects participate in an exercise program for eight
weeks. Within every week there are two group sessions. The subjects in the
program offered by the researcher will be asked to additionally perform
exercises at home on the remaining work days.
When participants are joining a program offered by a physiotherapist or MBVO,
only the tests will be performed on behalf of this study.
Collected data of all participants will be pooled.
Study burden and risks
During the week prior to the start of the intervention pretests will be
administered. Participants will also be asked to wear a hybrid sensor
underneath their clothes during the study period. There are no additional risks
in wearing this sensor.
Participants in the program offered by the researcher spend approximately four
hours per week for a total of ten weeks on study participation. During the
intervention period a one-hour group exercise program is offered twice a week.
On work days without group session participants are expected to perform a
customized exercise program at home for 30 minutes per day. Participation in
the study has the risks and benefits of an exercise program for balance
function and muscle function of the lower extremities. The main risks are
fatigue, muscle soreness and a risk of falling comparable to the risks in daily
activities.
Participants in an exercise program offered by MBVO or a physical therapist
spend only eight hours on study participation, because only the tests will be
performed on behalf of this study. For these elderly there are no personal
benefits of participation.
The safety of the participants will be guarded during training and testing
session.
A. Deusinglaan 1
9713 AV Groningen
NL
A. Deusinglaan 1
9713 AV Groningen
NL
Listed location countries
Age
Inclusion criteria
between 70 and 80 years old
performing ADL-activities independently
able to walk without walking aid for at least 10 m.
balance function as measured with Timed Up and Go and BBS somewhat deteriorated. (12 <= TUG <= 20) en (35 <= BBS <= 48)
Exclusion criteria
Severe co-morbidity which is of influence on mobility
Co-morbidity affecting the general condition of the participant, for example heart- or lung Diseases or neurological disorders
Insufficient cognitive functioning
Not able to understand or read Dutch instructions
Participation in other intervention studies in the same period of time
Participation in exercise programs aiming at improving balance and lower extremity muscle function
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 | NL32063.042.10 |