VITAMINE: The effectiveness of a tablet computer supported home-based exercise training program and optimal protein intake in community dwelling older adults to improve physical functioning; a randomized controlled trial

The world population is aging rapidly. As society ages, the incidence of
physical limitations is dramatically increasing. Physical limitations increase
the risk of falls, institutionalization, co-morbidity and premature death,
which increases health care expenditures and reduces quality of life. Increased
physical activity can prevent or treat the decline of physical functioning in
older adults. *More Exercise for Seniors* (Meer Bewegen voor Ouderen (MBvO) in
Dutch) is an organization that promotes physical activity for community
dwelling elderly people by organizing community based weekly group exercises.
Unfortunately, an evaluation showed that the program is not effective in
improving physical functioning and quality of life. Adjusting the training
program and improving the training adherence is needed to increase physical
funtioning and as such improve quality of life. In addition to improve physical
activity, adequate dietary protein intake has been shown to be important to
improve physical functioning in the older adults.

We aim to evaluate the effectiveness of 1) home-based exercise training program
supported by tablet computer and coaching on physical function and 2) increased
dietary protein intake during home-based exercise training program supported by
tablet computer and coaching on physical function in community dwelling older
adults.

The present study will be randomized, intervention trial with 3 parallel arms.
The full study comprises a screening, a 6 month intervention period and a 6
month follow-up (so a total duration of 12 months) After screening, Clusters of
participants (i.e. training groups) will be randomly assigned to one of the
following groups:

1. Control group (regular MBvO, or other comparable weekly exercise program,
group, n=80)
2. Home-based training program group supported by a tablet computer (VITA
group, n=80)
3. Home-based training program supported by tablet computer + Dietary protein
counselling group (VITA-Pro group, n=80)

Baseline, 6 months and 12 month follow-up measurements will be scheduled.

1. Control group (regular MBvO, or other comparable weekly exercise program,
group, n=80)
2. Home-based training program group supported by a tablet computer (VITA
group, n=80)
3. Home-based training program supported by tablet computer + Dietary protein
counselling group (VITA-Pro group, n=80)


Control program
Participants in the control group will participate in the weekly training
groups, supervised by an experienced trainer without any additional
intervention.

Home-based training program with tablet computer.
Participants in VITA and VITA-Pro will participate in the weekly training
groups, supervised by an experienced trainer. In addition, participants will
receive a home-based training program at least twice per week. Combined with
the regular training group, the participant will be physical active for >3
times a week, in order to meet the recommendations for physical activity.
The home-based training program is a functional training program with an
additional general physical activity plan. The exercises will focus on daily
activities such as climbing stairs, getting out of a chair and lifting
groceries, especially designed to improve physical performance and activities
of daily living. This home-based training program is developed by the Amsterdam
University of Applied Sciences based on the Functional Training for Elderly
(TNO), focus group discussions with older adults, expertise on physiotherapy
and occupational therapy, and expertise on movement sciences and physical
training.
The VITAMINE-application running on this tablet computer contains all content
to safely carry out the individualized training program at home and includes
instructional videos of each exercise. This application was also developed by
the Amsterdam University of Applied Sciences, based on user centered design,
making use of focus group discussions with older adults, expertise on
persuasive technology, user centered app development, and applied psychology.
The exercise protocol will be tailored to individual needs by trained and
supervised coaches. Recommendations for physical activity will be incorporated
in the general physical activity plan.
The coach will contact the participants on a weekly basis in the first two
months and will visit the weekly training group (MBvO) for further
individualization and to answer questions. Coaching intensity will be tailored
to individual needs, and after two months coaching intensity might be once a
month only.

Dietary protein counseling
Participants in the VITA-Pro receive dietary counseling to improve their
protein intake. Habitual dietary protein intake will be estimated at baseline.
Based on these results, the nutrition coach (dietetic students supervised by
dietician-lecturer-researcher) will provide a nutrition plan to improve dietary
protein intake. Dieticians will advise on the optimal amount (1.2-1.5 g per kg
body weight per day), timing (breakfast, lunch, dinner, snacks) and source of
protein (high quality protein sources, e.g. dairy protein) to improve body
composition and physical functioning. Participants will consume food products
available in supermarkets that are obviously considered safe. No protein
supplements will be used.


Coaching
Counseling and coaching instructions are based on the coaching manuals,
developed for the VITAMINE project by students and staff of the Amsterdam
University of Applied Sciences. All cooperating students are working in the
project for educational and research internship purposes. The students are
supervised and trained following ICH-GCP guidelines by the study team.

The risks associated with participation are minimal. Although muscle injury
might occur due to exercise, the risks are limited due 1) contra-indication to
un-supervised physical exercise will be excluded, 2) instructions via tablet
computer and practice of the exercises by the group and personal coaches.
Possible benefits, all participants gained insight in their overall health
status. Specific benefits for the intervention is six months personalized
training and possibly improvements in physical functioning.

Participants will visit the study location at Amsterdam University of Applied
Sciences 3 times in 12 months. During these visits body composition will be
determined, several physical tests will be conducted and they will complete
questionnaires.