|- candidate number||8199|
|- NTR Number||NTR2425|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jul-2010|
|- Secondary IDs||2010/67 METC VUmc|
|- Public Title||The effects of a combined functional gait- and strength training on stability of walking and rate of bone turn over in healthy elderly.|
|- Scientific Title||The effects of a combined functional gait- and strength training on stability of walking and rate of bone turn over in healthy elderly.|
|- hypothesis||1. The training program will result in improved stability of walking;|
2. The training program will result in improved rate of bone turnover (indicative of improvement in bone mass).
|- Healt Condition(s) or Problem(s) studied||Aging, Inactivity|
|- Inclusion criteria||1. 65-75 years;|
2. Male or femaie;
3. Community dwelling;
4. No active sports participation for at least 12 months.
Subjects are recruited via advertisementS in local newspapers.
|- Exclusion criteria||Vacscular-, neurological- or musculosceletal diseases that would interfere with the ability to walk, the use of walking aids or contra-indications for strength testing.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2010|
|- planned closingdate||1-feb-2011|
|- Target number of participants||40|
|- Interventions||The intervention consists of 16 weeks of twice weekly combined gait- and strength training in groups of maximally 10 subjects. Each training sessions has a duration of 1 hour. The training will be executed in a gym under supervision of an instructor.|
The training will consist of exercises that challenges balance during standing and walking (e.g. standing or walking on a compliant surface) and of exercises that improves muscle function of the lower extremities using body weight and, if possible, small external weights. The difficulty of the exercises will be adapted to individual capabilities.
The control group will not receive a training or other intervention during the trial. The control group will receive a delayed intervention after the final measurement.
|- Primary outcome||1. Stability of unperturbed walking (Local dynamic stability and variability of walking);|
2. Stability of perturbed walking (size of deflection from normal walking pattern and speed of return to normal walking pattern);
3. Indicators of bone turnover (markers of bonedegeneration: CTx; markers of bone synthesis: osteocalcine en P1NP).
|- Secondary outcome||1. (Changes in) quality of the heel bone (ultrasound);|
2. (Changes in) systemic growth factors (e.g. IGF-1 and Myostatin);
3. (Changes in) efficiency of walking (O2/kg/m);
4. Relation between (changes in) muscle performance parameters and (changes in) stability of walking;
5. Relation between (changes in) bone turnover parameters and (changes in) muscle performance parameters.
|- Timepoints||1. Baseline;|
2. Baseline + 16 weeks (post training);
3. Baseline + 24 weeks (follow up).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Marcel Toebes|
|- CONTACT for SCIENTIFIC QUERIES|| Marcel Toebes|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||Physical inactivity becomes more prominent as people age. Physical inactivity and ageing results in decreasing bone and muscle mass and decreased muscle functioning, which results in increasing difficulty in performing daily activities. Another problem with increasing age is the increased incidence of falls. Falls often lead to decreased functioning, reduced participation, early placement in nursing homes and premature death.|
The aim of this study is to investigate if a 16 weeks training program with combined functional gait and strength training results in improved stability of walking and improved bone turnover.
|- Main changes (audit trail)|
|- RECORD||2-jul-2010 - 5-aug-2010|