Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03739385 |
| Other study ID # |
2018-01123 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 10, 2018 |
| Est. completion date |
November 3, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
University of Basel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
During the past century, major demographic changes have occurred in Europe which primarily
affect the older age groups. According to the Swiss federal office of statistics, the number
of senior citizens has tripled (from 5.8% to 18.0%) while the number of young adults (younger
than 20 years old) has decreased from 40.7% to 20.1%. There is evidence that with increasing
age, physical activity and fitness level decreases. Additionally to lower physical activity,
natural aging results in a decrease of muscle strength and a modulation of afferent and
efferent reflex pathways due to a slowing down of neuromuscular performance. As a
consequence, there are multiple consequences on general health, disease and injury rates in
the older population such as a higher risk of sustaining fall injuries. An intergenerational
approach combining balance and strength promotion appears to possess great potential for
fall-prevention, for satisfying physical, social and behavioral need of children and seniors
as well as reducing health care costs due to increased inactivity in both age groups. No
studies have examined the effects of intergenerational exercise and health programs.
Description:
During the past century, major demographic changes have occurred in Europe which primarily
affect the older age groups. According to the Swiss federal office of statistics, the number
of senior citizens has tripled (from 5.8% to 18.0%) while the number of young adults (younger
than 20 years old) has decreased from 40.7% to 20.1%. Population projections indicate a
reinforcement of this population aging during the upcoming decades. There is evidence that
with increasing age, physical activity and fitness level decreases. Additionally to lower
physical activity, natural aging results in a decrease of muscle strength and a modulation of
afferent and efferent reflex pathways due to a slowing down of neuromuscular performance.
Hence, there are multiple consequences on general health, disease and injury rates in the
older population such as a higher risk of sustaining fall injuries. The etiology of falls is
multi-factorial comprising extrinsic / environmental factors (e.g. lighting, stairs, floor
surfaces, obstructed walkways, inadequate handrails etc.) and/or intrinsic / subject-related
risk factors. Two important intrinsic risk factors are deficits in static/dynamic postural
control and muscular imbalance and/or weakness. Interestingly, fall rates in seniors are
comparable to the ones in children caused by incomplete maturation. The risk of falling
during a lifespan is a U-shaped curve, with the highest risk being during childhood and after
reaching the age of 65 and older.
Many studies have been able to prove that adequate exercise training programs reduce
intrinsic fall factors in seniors. Up to date, guidelines concerning fall prevention in
children are limited to extrinsic factors only, and it is being postulated whether
fall-preventive training programs should be included in physical education curricula. The
development of effective and attractive fall-preventive intervention programs targeting
intrinsic fall factors are needed in order to improve physical determinants for reducing the
risk of falling in both groups. Up to date, children and seniors have been examined and
trained separately to improve physical fitness parameters. An intergenerational approach
combining balance and strength promotion appears to possess great potential for
fall-prevention for children and seniors as well as reducing health care costs due to
increased inactivity in both age groups.
Research has been able to link social-emotional competencies to early school success and the
growth of academic competence during elementary school. Emotional and social skill
development which are basic elements of social interactions such as the affective social
competence of an individual, are developed during early childhood and should be encouraged
during those stages. As children's social interactions increase in frequency and complexity,
they must learn to comprehend even emotionally difficult situations, they should be able to
set prosocial goals and determine effective ways to solve differences with peers as well as
adults. A child's social-emotional learning should also include relationship skills. In order
to build and maintain positive exchanges and satisfying relationships over time, one must
acquire numerous skills such as joining others in play, initiating and maintaining
conversations, cooperating, listening, and taking turns. Additionally, the attitudes as well
as the forming of stereotypes against the elderly develop early and remain fairly constant,
posing a strong influence on their future behavior towards others. An intergenerational
setting has the potential of providing an additional challenge to a child's social-emotional
learning as well as preventing prejudice against the aged. By exposing children to a new and
unknown setting, they are forced to adapt socially, thus promoting their social and emotional
learning abilities while positively influencing their view and attitudes towards old age.
Additionally, studies examining the effects of exercise on children have confirmed that
exercise has positive effects on social behavior, classroom behavior and several aspects of
academic performance as well as on general health-related quality of life in children.
The aging process entails diverse and distinctive cognitive changes which are primarily
influenced by environmental factors and lifestyle along with functional changes due to
biological effects. The aging process increases the risk of succumbing to a variety of
neurological disorders including depression, Parkinson's disease, Alzheimer's dementia and
ischemic stroke. The decline in cognitive functions has been linked to a decrease in physical
and social activities. As a result, quality of life starts to decline, independent living
cannot be sustained, social interactions are diminished, chronic diseases such as diabetes,
hypertension and higher cardiovascular risks negatively impact general health and a decline
in muscular force, flexibility as well as agility and balance impacts daily activities.
Decrease in cardiopulmonary function was reported to damage cerebral cortex causing central
nervous system disorders, which decrease overall brain function. Both long-term research from
cross-sectional studies and short-term research from randomized controlled clinical trials
suggest that physical activity and fitness training influences brain structure and function
positively, thus combating the aforementioned neurological disorders. Aerobic exercise has
been shown to be a valid therapeutic measure to combat late-life depression and increased
physical fitness is a premise for maintaining cognitive functioning as well as executive
functioning in seniors.
Physical inactivity, as previously established, is one of the main causes for falls in
seniors on one hand, and a protective factor for succumbing to neurological disorders in the
aging process on the other hand. Programs to promote physical activity in the elderly is of
great interest to combat diseases, improve quality of life and providing a social network as
well as reducing risk of falling, and effective programs and methods for exercise and
activity promotion in seniors are therefore of great interest and importance. To implement a
successful physical activity promotion program in order to counter the effects of inactivity
and achieve desirable health outcomes, the target groups must adhere to regular physical
activity. Evidence suggests that physical activity promotion intervention amongst older
adults are generally effective when the motivators to them are suitable such as social,
individual and environmental support, and that prevention programs fail due to the lack of
target group-oriented approach. To ensure that health measures reach the elderly, it is
necessary to formulate messages more relevant to older people and to tailor information to
their specific needs and preferences. Older seniors identify the health benefits of physical
activity in terms of reducing the effects of aging and being fit to play with grandchildren
and are more likely to name personal responsibility and moral obligation to maintain one's
health as their motivator for participating in preventive health sports and physical
activities. Motivation is a key determinant of physical activity behavior, and reports of
sizeable attrition from programs of structures physical activity for older adults and from
personal home-based regimens confirm that maintaining the motivation for the necessary
adherence is often a challenge.
Intergenerational exercise groups possesses the potential to becoming an innovative strategy
for promoting physical activity in seniors. An intergenerational approach combining balance
and strength appears to possess great potential for fall-prevention, for satisfying physical,
social and behavioral need of children and seniors as well as reducing health care costs due
to increased inactivity in both age groups. Preliminary data indicates that intergenerational
relationships affect and influence participants of exercise programs by providing motivation
for seniors to exercise more regularly when children are included and to increase the
seniors' self-esteem. They are an opportunity to improve social integration, tolerance,
social responsibility as well as the development of social and emotional skills. Through
shared physical activities in which the generations alternate their support and help, both
age groups can achieve beneficial effects on psychological, social, emotional and physical
factors. As aforementioned, up to date children and seniors have been examined and trained
separately to improve physical fitness parameters, and no evidence exists on how
intergenerational exercise programs benefit not only physical health but also
social-emotional skills and psychological wellbeing. Even though no studies have examined the
effects of intergenerational exercise and health programs, intergenerational approaches have
been made in social, musical and artistic settings with promising preliminary outcomes in
terms of mutual understanding, tolerance and social belonging. An intergenerational setting
possesses the potential of providing an additional challenge to a child's social-emotional
learning as well as preventing prejudice against the aged. By exposing children to a new and
unknown setting, they are forced to adapt socially, thus promoting their social and emotional
learning abilities while positively influencing their view and attitudes towards old age.
Additionally, studies examining the effects of exercise on children have confirmed that
exercise has positive effects on social behavior, classroom behavior and several aspects of
academic performance as well as on general health-related quality of life in children. In
regard of the aforementioned fall incidence in both age groups, a combined exercise program
targeting intrinsic fall-factors (impaired static and dynamic postural control as well as
deficits in muscle strength) could reduce fall-risk and in turn reduce fall-related costs.
Considering this background, the proposed study aims at comparing the effects of
intergenerational exercise training compared to peer-group exercise training and control
groups on parameters of psychological wellbeing and physical health. Psychological wellbeing
include quality of life, fear of falling, mental health, independent living, pain, social
participation and coping for seniors, while the children will be assessed on their emotional
and social capabilities such as prosocial behavior, cooperation, empathy, emotional
regulation and their view on aging. Physical health parameters include functional mobility,
static and dynamic balance as well as cardiovascular health.
The following main research questions will be addressed:
- Do the three exercise training groups differ in adherence to exercise program?
- Do the three intervention groups differ in terms of improving psychological wellbeing?
- Do the three intervention groups differ in terms of changes in functional mobility,
balance and cardiovascular health?
The research can be categorized in the risk category A according to the local ethics
committee. Measurements are non-invasive and represent no risk for participants. The
intervention consists of a psychological and physical health benefitting exercise programs.
The study corresponds to Category A risk for activity-related adverse events are similar or
lower than independent physical activity participation.
