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Generations on the Move (GIB-Study): Intergenerational Exercise and Health Promotion (GIB)

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ClinicalTrials.gov Identifier: NCT03739385
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Henner Hanssen, University of Basel

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.

Condition or disease Intervention/treatment Phase
Physical Activity Other: Exercise Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 with a 3-month follow-up period (Figure 1). 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 three occasions in all five groups: before intervention start (M1), after the intervention period (M2) and after a 3-month follow-up period (M3).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Generations on the Move: Intergenerational Exercise and Health Promotion
Estimated Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intergenerational Group
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
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.

Active Comparator: Peer Group Children
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
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.

Active Comparator: Peer Group Seniors
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
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.

No Intervention: Control Group Children
Pre-School children will be assessed during pre-, post- and follow-up testing procedures but will receive no exercise intervention.
No Intervention: Control Group Seniors
Residential seniors will be assessed during pre-, post- and follow-up testing procedures but will receive no exercise intervention.



Primary Outcome Measures :
  1. Number of attended exercise sessions [ Time Frame: 25 weeks intervention ]
    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).


Secondary Outcome Measures :
  1. Quality of Life, AQoL-8D Score [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is quality of life using the Assessment of Quality of Life, 8D (AQoL-8D). Scale ranges for single questions are from 1 to 5, whereby the total score is calculated by the sum of the individual scores. Lower scores represent a high quality of life, while high scores stand for low quality of life.

  2. Independent Living [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is Independent Living using the Assessment of Quality of Life (AQoL-8D). Scale ranges for single questions are from 1 to 5, whereby the total score is calculated by the sum of the individual scores. Lower scores represent a high independency, while high scores stand for low independency.

  3. Mental Health [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is Mental Health using the Assessment of Quality of Life Questionnaire (AQoL-8D). Scale ranges for single questions are from 1 to 5, whereby the total score is calculated by the sum of the individual scores. Lower scores represent good mental health while higher scores represent bad mental health.

  4. Fear of Falling [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is Fear of Falling using the Fall Efficacy Scale (FES). Sore ranges for individual questions range from 1 to 4, whereby the total score of all 16 questions is the total score. Low values show a low fear of falling while high scores represent a great fear of falling.

  5. General Health [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is General Health using the 36-Item Short Form Survey (SF 36). Answers are scored individually according to a template whereby the range is from 0 points (very low health) to 100 (excellent health). The mean value of questions represent the general health, whereby low values represent low health and high scores represent good general health.

  6. Gait Analysis [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is time (in seconds) needed during a 10m gait analysis.

  7. Chair to Rise Test [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is time (in seconds) needed to stand up and sit back down five consecutive times

  8. Static Balance [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors is path length (mm) during a 10-second tandem balance test

  9. Grip Force [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors and children ist force (N) of their grip, assessed using the Automated Grip Force Assessment protocol of the Leonardo Mechanograph.

  10. Arterial Stiffness [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for seniors and children ist Pulse Wave Velocity (PWV)

  11. Prosocial Behavior [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children ist Prosocial Behavior using the Strengths and DIfficulties Questionnaire (SDQ), filled out by their parents. Answers are rated from 1 to 2 points and the total score is the sum of the individual scores. Low total scores represent no difficulties while higher scores show difficulties.

  12. Emotion Regulation [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children ist Emotion Regulation using the "Competences and Interests of Children" (KOMPIK) Questionnaire. Answers are scored on a scale of 1 to 5, whereby the mean value of individual scores represent the total score. Higher values represent a strong capacity for emotion regulation, while low scores indicate low capacity of emotion regulation.

  13. Empathy [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children ist Emotion Regulation using the"Competences and Interests of Children" (KOMPIK) Questionnaire. Answers are scored on a scale of 1 to 5, whereby the mean value of individual scores represent the total score. Higher values represent a strong capacity for empathy, while low scores indicate low capacity of empathy.

  14. Psychological Wellbeing [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children ist Emotion Regulation using the "Competences and Interests of Children" (KOMPIK) Questionnaire. Answers are scored on a scale of 1 to 5, whereby the mean value of individual scores represent the total score. Higher values represent high psychological wellbeing, while low scores indicate low psychological wellbeing.

  15. Social Relationships [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children ist Emotion Regulation using the "Competences and Interests of Children" (KOMPIK) Questionnaire. Answers are scored on a scale of 1 to 5, whereby the mean value of individual scores represent the total score. Higher values represent a strong capacity for social relationships, while low scores indicate low capacity of social relationships.

  16. Gross Motor Skills [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children are fundamental movement skills using the Test of Gross Motor Development (TGMD-2) Test Battery

  17. Peak Power [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children are peak power during a single, two-legged jump on a force plate

  18. Arterial-to-venular Ratio [ Time Frame: 1 Year (Pre-, post and follow-up measurements) ]
    Secondary outcomes for children is arterial-to-venular ratio assessed during static vessel analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739385


Contacts
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Contact: Lukas Zahner, Prof. Dr. 061 207 47 37 ext 0041 lukas.zahner@unibas.ch
Contact: Alice Minghetti, MSc 061 207 47 14 ext 0041 alice.minghetti@unibas.ch

Locations
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Switzerland
Department of Sport, Exercise and Health, University of Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4052
Contact: Lukas Zahner, Prof. Dr.    061 207 47 37    lukas.zahner@unibas.ch   
Contact: Alice Minghetti, MSc    061 207 47 14    alice.minghetti@unibas.ch   
Sponsors and Collaborators
University of Basel
Investigators
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Principal Investigator: Lukas Zahner, Prof. Dr. Department of Sport, Exercise and Health, University of Basel
Study Chair: Henner Hanssen, Prof. Dr. Department of Sport, Exercise and Health, University of Basel

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Responsible Party: Henner Hanssen, Professor, University of Basel
ClinicalTrials.gov Identifier: NCT03739385     History of Changes
Other Study ID Numbers: 2018-01123
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henner Hanssen, University of Basel:
Intergenerational
Exercise
Health