The objective of the study is to investigate the feasibility of a combined resistance exercise training (RET) and protein supplementation (ONS) intervention and explore the effect on muscle mass and other parameters compared to standard of care in…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility (adherence to intervention and drop-out rate) and effect of the
intervention on muscle mass.
Secondary outcome
Effect of the intervention on muscle strength, physical and functional
performance, quality of life, mobility, nutritional status, nutritional intake,
length of stay in geriatric rehabilitation, institutionalisation/
hospitalisation and mortality.
Background summary
Sarcopenia and (risk of) malnutrition are estimated to be present in 56% and
47% of geriatric rehabilitation patients respectively. Resistance exercise
training (RET) combined with protein supplementation has been recommended to
increase muscle mass and strength in older adults. However, feasibility and
efficacy in a geriatric rehabilitation setting remains to be established. The
EMPOWER-GR RCT will test the hypothesis that a combined intervention of RET and
protein supplementation with an oral nutritional supplement (ONS) is feasible
in sarcopenic geriatric rehabilitation inpatients and increases muscle mass
during the stay in geriatric rehabilitation and after discharge.
Study objective
The objective of the study is to investigate the feasibility of a combined
resistance exercise training (RET) and protein supplementation (ONS)
intervention and explore the effect on muscle mass and other parameters
compared to standard of care in sarcopenic geriatric rehabilitation inpatients
at discharge and at week 13.
Study design
Feasibility, single-centre, randomised, controlled, open-label, parallel-group
study.
Intervention
The intervention group will receive a combined RET (3x per week) and protein
supplementation (ONS, 2x per day) intervention on top of standard of care and
the control group will receive standard of care for a total duration of 13
weeks. In most cases, the intervention will continue after discharge from the
revalidation centre, with a total study duration of 13 weeks for all subjects.
Study burden and risks
The burden of the study on top of standard of care is limited. All subjects
will attend a screening visit and 3 study visits (4h each but the majority of
the tests are part of standard of care): 2 visits during their stay in
geriatric rehabilitation and 1 visit after discharge. All the measurements are
commonly used in clinical practice, non-invasive and entail a low burden for
the participants. Besides the study visits, subjects will complete a 3-day
dietary record at three time points. Also, subjects in the intervention group
will follow 3 RET sessions (45min) per week with a physiotherapist
(physiotherapists sessions are also part of standard of care) and consume the
ONS twice daily. The subjects will benefit from a Comprehensive Geriatric
Assessment, providing further insights in their muscle health and other key
clinical outcomes.
Van der Boechorststraat 7-9
Amsterdam 1081BT
NL
Van der Boechorststraat 7-9
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
- Admitted to a geriatric rehabilitation centre of Cordaan.
- Aged 65 years or older.
- Diagnosed with sarcopenia.
- Written informed consent.
Exclusion criteria
- Palliative care or other adverse prognosis precluding post-intervention
follow-up
- Rehabilitation after stroke or cancer
- Specific medical history that could prevent participation in the intervention
or affect the study outcome as judged by the investigator
- BMI >40 kg/m2 (morbid obesity)
- Renal impairment
- Unable to provide informed consent (patient or legal representative)
- Not understanding Dutch
- Investigator's uncertainty about the willingness or ability of the subject to
comply with the protocol requirements
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 | NL74989.029.20 |
| Other | NL9444 |