This intervention study investigates the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise training for 3 months on bone and muscle health, and quality of life in older adults recovering from an acute hip…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Bloodmarkers: P1NP, IGF-1, PTH
* Bone mineral density: total hip, femoral neck, and total body
* Physical performance
* Muscle mass
Secondary outcome
* Quality of life
* Inpatient rehabilitation time
* Daily life functioning
* Fear of falling
* Stress
* Levels of (free) 25(OH)D, folate, vitamin B12, and vitamin C
Background summary
A hip fracture jeopardizes the health status and quality of life of older
adults. Only half of the patients regain their pre-fracture functional level
and 24% dies within the following year. The risk of reoccurring fractures and
increased mortality persists for at least 10 years following the initial
fracture. Targeting modifiable risk factors, such as osteoporosis and
sarcopenia, are therefore a major area of interest. A high protein intake and
resistance exercise may be beneficial for older hip fracture patients, it may
improve clinical outcomes, and slow down postoperative bone and muscle loss.
The current study will investigate a unique study population; not much
attention is given to the rehabilitation as setting.
Study objective
This intervention study investigates the effectiveness, costs and
cost-effectiveness of a protein-enriched diet and resistance exercise training
for 3 months on bone and muscle health, and quality of life in older adults
recovering from an acute hip fracture.
Study design
This study will be a 3-month randomized, controlled, parallel-group trial.
Intervention
There will be two groups, an intervention group receiving a tailor-made
protein-enriched diet and an extended exercise training program, and a control
group receiving usual care.
Study burden and risks
Following a protein-enriched diet for 3 months requires an adaption in the
subjects* dietary habits, but these changes will be tailor-made by consultation
with a dietician in order to make the subjects feel comfortable with the diet.
Most measurements are part of usual care and are therefore considered to impose
no extra burden on subjects. A protein intake of 1.5 g/kg bw/d is safe and
probably needed for both bone and muscle health in our study population, as
recommended by several expert groups. People with disorders/diseases where a
high protein intake can be harmful will be excluded from the study. Concerning
the benefits, this study will lead to knowledge about the impact of protein and
exercise on bone and muscle health outcomes in older adults. It is hypothesized
that a higher protein intake and resistance exercise training have a beneficial
effect on bone and muscle health outcomes and subsequently leads to a shorter
rehabilitation time and a better quality of life.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
* Age >= 65 years
* Acute hip fracture
* Able to give written informed consent
* Mentally competent, as judged by the treating physician
* Admission to a rehabilitation centre that participates in this research
Exclusion criteria
* Allergic, intolerant or hypersensitive to milk/lactose (self-reported)
* Not willing to stop using dietary supplements with the exception of calcium
and vitamin D
* Pathological fracture or periprosthetic fracture
* Abnormal hepatic or renal laboratory parameters, such as estimated glomerular
filtration rate (eGFR) <30 ml/min/1,73 m2 (data from hospital)
* Diagnosis of disorders/diseases where a high protein intake can be harmful,
such as renal impairment or failure, or liver disease (elderly care physician
has the decisive voice).
* Diagnosis of bone metabolic disorders such as primary hyperparathyroidism,
Paget*s disease, or myeloma
* Taking medication other than bisphosphonates known to strongly alter bone,
calcium or muscle metabolism, such as oestrogen, hormone replacement therapy,
corticosteroids, anabolic agents or calcitonin.
* Disorders/diseases which may affect ability to follow study protocol and
which cannot be overcome with help of a caregiver
* Current participation in other scientific research
* No permission to request information from the general practitioner/ treating
specialist(s) about medical history, medication use, liver and kidney values,
and details about the broken hip
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68932.081.19 |
| Other | NTR: NL7554 |