|- candidate number||8211|
|- NTR Number||NTR2407|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jul-2010|
|- Secondary IDs||311060302 ZonMW|
|- Public Title||Training of the ability to live independently 75+.|
|- Scientific Title||Effect of functional training on the ability of frail elderly of 75 years and older to live independently.|
|- hypothesis||The aim of this study is to determine the (cost)effectiveness of a home-based functional training programme as compared to regular physical therapy with regard to the ability to live independently and participation of frail elderly of 75 years and older with problems in physical functioning. |
The home-based intensive functional training programme focuses on training of those daily activities which are problematic for the elderly. We expect that particularly in frail older people with multiple problems in daily functioning, functional training can improve their ability to live independently, especially when it will be delivered individually and in the older persons' homes.
|- Healt Condition(s) or Problem(s) studied||Mental health, Frailty, Physical functioning, Social functioning, Somatic symptoms|
|- Inclusion criteria||1. 75 years or older;|
2. Living independently;
3. Problems in physical functioning (restraints in daily activities) and, in addition, problems in at least one of the following domains: Somatic, mental and social functioning;
4. Understanding questions and instructions.
|- Exclusion criteria||1. Terminal illness (life expectancy less than 3 months);|
2. Planned surgery within 3 months;
3. Physiotherapy or exercise therapy at the moment of inclusion;
4. Contra-indication for physical exertion (assessed by general practitioner).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2010|
|- planned closingdate||31-mrt-2012|
|- Target number of participants||128|
|- Interventions||The elderly in the functional training programme will be referred to a physiotherapist who has been specially educated to deliver the functional training programme in the older person's home. In the functional training programme (maximum of 18 sessions) the daily activities experienced as troublesome by the participant are trained in the home situation. The intensity and repetitions of the exercises are progressively increased over time and performed in progressively more challenging ways such as double tasking. To achieve a long-term effect, the physiotherapist will guide the participant during the training programme in regular and safe physical activity and thus stimulate the participant to more physical activity at home and in the neighbourhood. |
In addition, caretakers can be called in for guidance in the home situation to stimulate the participant to perform daily activities and to stay active. This preventes caretakers take needlessly daily activities off the participant's hands.
The elderly in the control group will receive regular physical therapy
(usually consisting of muscle exercises, balance exercises and walking
exercises) (maximum of 18 sessions) from a physiotherapists who has not
been educated in the functional training programme.
|- Primary outcome||The ability to live independently and participation, as measured with the Physical Performance Test and the questionnaire User-Participation.|
|- Secondary outcome||1. Perceived health state;|
2. Quality of life;
3. Restraints in important daily activities;
4. Psychological and social functioning;
5. Level of physical activity;
6. Fall incidents;
7. Use of care;
8. Treatment satisfaction;
9. Perceived effect;
|- Timepoints||T0: Baseline measurement before randomization and start of therapy.|
T1: 4 months after T0 (after finishing therapy).
T2: 8 months after T0.
T3: 12 months after T0.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Arlette Hespen, van|
|- CONTACT for SCIENTIFIC QUERIES|| Arlette Hespen, van|
|- Sponsor/Initiator ||TNO Quality of Life (Work and Employment)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The functional training programme, in contrast to traditional exercise
programmes, focuses on training of those daily activities which are
problematic for the elderly. We expect that particularly in frail older
people with multiple problems in daily functioning, functional training
can improve their ability to live independently, especially when it will
be delivered individually and in the older persons' homes.
The aim of this study is to measure the (cost)effectiveness of a
functional training programme delivered in the older persons' homes as
compared to traditional physical therapy with regard to the ability to
live independently and participation of frail elderly of 75 years and
older with problems in physical functioning.
The study consists of two parts: a screening study and an intervention
study. By means of a short screening questionnaire (via general
practitioner) frail elderly will be traced. A research staff member of
the LUMC will visit the frail elderly at home to check whether the older
person meet the inclusion criteria of the intervention study
'Physiotherapy 75+'. Their general practitioner will check whether
physiotherapy is safe and give them a referral for physiotherapy. This
is the start of the intervention study. A research staff member of TNO
will visit these elderly at home for a baseline measurement
(questionnaires and physical tests) and will ask informed consent to
participate in the study. Subsequently, the elderly will be randomized
to the functional training programme (n=75) or regular physical therapy
(n=75). Follow-up measurements will take place 3, 6 and 12 months later.
The study populations consists of persons of 75 years and older living
at home who have problems with physical functioning as well as problems
of somatic, psychological and/or social nature.|
|- Main changes (audit trail)|
|- RECORD||6-jul-2010 - 27-jul-2010|