ProMuscle 65PK: feasibility and potential impact of a physical activity and nutrition intervention in practice for community dwelling elderly people receiving home care: A pilot study

Sacropenia is the age associated loss of skeletal muscle mass and function.
Loss of muscle mass and strength has several health consequences, such as
reduced physical functioning, and a possible increased risk of development of
chronic diseases. This can lead to difficulties with everyday activities, like
walking stairs, rising from a chair and from a bed. Impairments in physical
functioning can contribute to loss of independence, and thus an important
barrier for social participation and independent living. Research shows that
the combination of resistance exercise and protein supplementation are good
strategies to counteract the loss of muscle strength, muscle mass, and physical
functioning in elderly people. Due to changes in the elderly care in the
Netherlands the elderly are expected to live longer independently at home. In
the current pilot study it will be tested whether an adapted clinical effective
intervention is feasible to implement in practice (care-setting).

The primary objective of this pilot study is to study the feasibility of
implementation of the ProMuscle 65PK in a real-life setting. Besides that, the
potential impact of the intervention will be studied on muscle health and
physical performance outcomes, and to verify whether a future effectiveness
study should be performed.

This study is a pilot study of 12 weeks, with a one group pre-test post-test
design, with on-going process measures.

For twelve weeks, subjects will receive the ProMuscle 65PK intervention. All
participants will perform both resistance exercise and increase their protein
intake during the study. Subjects perform progressive resistance exercise twice
a week, one hour per training, in small groups. Trainings are supervised by
certified physiotherapist; during performance of the exercises there is always
one-on-one guidance. The trainings start with a warming-up, followed by
exercises for the major muscles, and a cooling-down. The training intensity is
always tailored to the individuals abilities. The dietary protein intake will
be increased based on an advice of a dietician. The dietician advises how to
increase the protein intake during the main meals, using protein-rich dairy
products. They aim to reach at least 25 grams of protein during the main meals.

The study measures are non-invasive. Measurements will take some time and
effort from the participants, but this is only at baseline and after the twelve
weeks. The resistance exercise and maximal strength measures (3 -RM) are
supervised by skilled trainers, that ensures safe performance of all exercises.
The exercises will be tailored to the subjects abilities. These trainings might
result in feelings of muscle soreness, but these will fade in a few days. The
protein products are made from normal nutritional ingredients, are subject to
strict safety regulations at FrieslandCampina, and will be tested according to
the microbial specification for food safety for the specific products. Since
the trainings are twice a week for one hour at a time, subjects are able to
continue to engage in their normal daily activities. There is no restriction in
food products during the study. The protein products will be provided during
the study, and choice will be offered through different types and flavours of
products. After full completion of the study, subjects receive a small reward
in the form of a credit note. The subjects can quit the study at any time, for
any reason, if they wish to do so. Previous research showed that the
combination of resistance exercise and protein improves muscle strength, muscle
mass and physical performance in daily life. Subjects will receive an overview
of their personal results on the tests that will be performed at the end of the
study.