ProMuscle in Practice: Effectiveness of a combined resistance exercise and nutrition intervention to promote maintenance of physical functioning of community-dwelling elderly in a real-life setting

Sarcopenia 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, a higher chance to develop
chronic metabolic diseases and a higher chance of institutionalisation. Those
factors are important barriers for social participation and independent living.
Research shows that the combination of resistance exercise training 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 a previous phase, the experimental intervention has
been adapted to fit the real-life setting and was pilot-tested for feasibility.
In the current multicentre randomised controlled trial the (cost-)effectiveness
and feasibility of an adapted experimental intervention, that combines
resistance exercise and extra dietary protein intake, in a real-life setting
(care).

The primary objective of this study is to study the effectiveness of the
adapted experimental intervention in a real-life setting on muscle- and health
outcomes, and quality of life of community-dwelling (pre-)frail elderly.
Furthermore, effectiveness of the maintenance program, and cost-effectiveness
and cost-utility of the intervention will be assessed, compared to usual care.
Feasibility and acceptance of the intervention at the different settings will
also be extensively studied.

This study is a randomised, controlled, multicentre, phased intervention trial
with a parallel design. The intervention group receives the combined nutrition
and exercise intervention for 12 weeks, and subsequently a maintenance period
of 12 weeks (in which they will be informed and familiarized with local
exercise and nutrition options). The control group receives only usual care for
the first 24 weeks, but also receives the 12 week maintenance period after 24
weeks. Effectmeasures, and measures related to care costs will be performed at
baseline, after 12 weeks and after 24 weeks in both study groups, and also
after 36 week. Follow-up measurements will be performed on healthcare use,
quality of life and physical functioning in week 52 (only the first three
locations). Process measures will be performed during the complete study
period.

All intervention-group participants will perform resistance exercise training
and will increase their dietary protein intake, during week 1 * 12. The
progressive resistance exercise trainings will be twice a week, for 1 hour per
training, in a small training group. Participants receive intensive guidance
from a physiotherapist during the training sessions; they pay attention to the
safe and correct execution of the exercises. The training consists of a
warming-up, exercises for the major muscle groups, and a cooling-down. The
exercise intensity is tailored to the strength of the individual participants.
The protein intake is increased based on advice by a dietician. This dietician
advises the participant on increasing the protein intake in the main meals,
using protein rich products, which can be either added to the meal or used as a
substitution for other products. The aim of the nutrition program is to achieve
a protein intake of at least 25 grams at each main meal. Halfway during the
intervention period, an evaluation consultation will be scheduled with the
dietician, to evaluate the nutrition program and make adjustments to the advice
if necessary.
During the maintenance period (week 13-24 for the intervention group, week
25-36 for the control group), participants are informed about and facilitated
towards local exercise- and nutrition possibilities. This is done to help them
to independently continue or start with the exercise and consumption of protein
rich foods.

The study measures are non-invasive. Next to questionnaires and short
interviews, a number of tests will be performed to assess muscle strength and
physical functioning. Measurements will take some time and effort from the
participants. The resistance exercise and maximal strength measures (3 *RM) are
supervised by skilled trainers, who ensure safe performance of all exercises.
The exercises will be tailored to the participants' abilities. These trainings
might result in feelings of muscle soreness, but those will fade in a few days.
The protein products are made from normal nutritional ingredients, are subject
to strict safety regulations at FrieslandCampina and Innopastry, 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.
During the maintenance period, participants are free to do what they want, they
are not forced to continue with the exercise or eating protein rich foods.
Participants are free to stop with the study at any time, for any reason, if
they wish to do so. Besides a financial compensation, it is expected that
participants benefit from the intervention and maintenance period. Previous
research showed that the combination of resistance exercise and protein
improves muscle strength, muscle mass and physical performance. Being informed
with facilities in the local community can help them to maintain a healthy
lifestyle. Participants will receive an overview of their personal results on
the tests that will be performed at the end of the study.