NCT03739385

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

October 11, 2018

Last Update Submit

November 5, 2020

Conditions

Keywords

IntergenerationalExerciseHealth

Outcome Measures

Primary Outcomes (1)

  • Number of attended exercise sessions

    Primary outcome is adherence to the exercise intervention. Adherence corresponds to the total number of attended training sessions by each participant. Adherence will only be measured in the three intervention groups (intergenerational group, peer group seniors, peer group children).

    25 weeks intervention

Secondary Outcomes (18)

  • Quality of Life, AQoL-8D Score

    1 Year (Pre- and post measurements)

  • Independent Living

    1 Year (Pre- and post measurements)

  • Mental Health

    1 Year (Pre- and post measurements)

  • Fear of Falling

    1 Year (Pre- and post measurements)

  • General Health

    1 Year (Pre- and post measurements)

  • +13 more secondary outcomes

Study Arms (5)

Intergenerational Group

EXPERIMENTAL

Pre-school children and residential seniors will receive two weekly exercise training sessions lasting 45 minutes each. All exercise training sessions are conducted by professional exercise coaches and are planned in a progressive and variable manner. The training sessions focus on balance and fundamental movement skills.

Other: Exercise Intervention

Peer Group Children

ACTIVE COMPARATOR

Pre-school children will receive two weekly exercise training sessions lasting 45 minutes each. All exercise training sessions are conducted by professional exercise coaches and are planned in a progressive and variable manner. The training sessions focus on balance and fundamental movement skills.

Other: Exercise Intervention

Peer Group Seniors

ACTIVE COMPARATOR

Residential seniors will receive two weekly exercise training sessions lasting 45 minutes each. All exercise training sessions are conducted by professional exercise coaches and are planned in a progressive and variable manner. The training sessions focus on balance and fundamental movement skills.

Other: Exercise Intervention

Control Group Children

NO INTERVENTION

Pre-School children will be assessed during pre-, post- and follow-up testing procedures but will receive no exercise intervention.

Control Group Seniors

NO INTERVENTION

Residential seniors will be assessed during pre-, post- and follow-up testing procedures but will receive no exercise intervention.

Interventions

The training interventions of all three groups (intergenerational group, peer group seniors, peer group children) will occur under professional supervision twice a week lasting over a 25-week period with training sessions lasting 45 minutes each. Control groups (control group seniors, control group children) receive no intervention.

Intergenerational GroupPeer Group ChildrenPeer Group Seniors

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy seniors of at least 65 years of age.
  • Healthy children in the 2 years of kindergarten between the ages of 4 and 7 are included.

You may not qualify if:

  • Chronic and / or congenital heart failure
  • Peripheral arterial occlusive diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport, Exercise and Health, University of Basel

Basel, Canton of Basel-City, 4052, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Oliver Faude, PD. Dr.

    Department of Sport, Exercise, and Health, University of Basel

    PRINCIPAL INVESTIGATOR
  • Henner Hanssen, Prof. Dr.

    Department of Sport, Exercise, and Health, University of Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study is designed as a five-armed, cluster-randomized controlled trial with a 25-week (distributed over a school year) physical exercise training intervention. After preliminary assessment (written consent, questionnaires, personal data) the institutions with their participants will be randomly assigned to either the intergenerational group (INT), the two peer-groups PGS (peer group seniors) and PGC (peer group children) or the two control groups CONS (control group seniors) or CONC (control group children). Measurements of psychological wellbeing and physical health will occur on two occasions in all five groups: before intervention start (M1) and after the intervention period (M2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2018

First Posted

November 13, 2018

Study Start

November 10, 2018

Primary Completion

September 30, 2019

Study Completion

November 3, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations