Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03858114
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2019-02-13
Brief Title:
Active Ageing and Health
Sponsor:
University of Cagliari
Organization:
University of Cagliari
Study Overview
Official Title:
Active Ageing and Health
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background 36 of the Italian population will have more than 65 years in 2050 The European Union has indicated among its priorities to increase research on active aging Physical activity contrasts disability linked to chronic diseases has positive effects on the quality of life and on biological rhythms prevents the decline of motor functions improves the immune response and prevents positively affects metabolic disorders It also provides valuable support in coping with cognitive decline and memory and acts on depressive symptomatology
The literature on active aging is based to date on studies with small samples rarely conducted with a randomized controlled method whose outcomes often appear contradictory
The multidisciplinary project the investigators propose is an opportunity to address the issues mentioned above and to acquire further knowledge in the field of active aging
Objectives the main objective of the study is to evaluate the effects of mild-to-moderate physical activity in a sample of over-65 years-old persons on Quality of Life and on biomechanical parameters static-dynamic balance mobility The secondary objectives are aimed at assessing whether a protocol of mild-to-moderate physical activity can improve
Metabolic functions
Cognitive performance
Perception of pain
Social rhythms and psychological wellbeing
Inflammatory state Design randomized controlled trial RCT single-blinded with follow-up
Sample participants will be 65 years old of both genders sedentary enrolled in two arms through a random assignment treatmentcontrol with ratio of 11 as following
about 60 subjects who will carry out a light-to-moderate physical activity intervention experimental group
about 60 subjects in the control group who will participate in group cultural activities active comparison group
Assessment the assessment will include socio-demographic variables variables of psychophysical wellbeing cognitive variables variables related to physical health biomechanical variables assessment of skin integrity lab tests on blood samples
Times of evaluations both groups will be subjected to the measurements of the present study according to the following schedule
T0 baseline before the start of the intervention
T1 12 weeks after T0 at the end of the intervention
T2 after 20 weeks from T0 follow up 1
T3 48 weeks after T0 follow-up 2
The literature on active aging is based to date on studies with small samples rarely conducted with a randomized controlled method whose outcomes often appear contradictory
The multidisciplinary project the investigators propose is an opportunity to address the issues mentioned above and to acquire further knowledge in the field of active aging
Objectives the main objective of the study is to evaluate the effects of mild-to-moderate physical activity in a sample of over-65 years-old persons on Quality of Life and on biomechanical parameters static-dynamic balance mobility The secondary objectives are aimed at assessing whether a protocol of mild-to-moderate physical activity can improve
Metabolic functions
Cognitive performance
Perception of pain
Social rhythms and psychological wellbeing
Inflammatory state Design randomized controlled trial RCT single-blinded with follow-up
Sample participants will be 65 years old of both genders sedentary enrolled in two arms through a random assignment treatmentcontrol with ratio of 11 as following
about 60 subjects who will carry out a light-to-moderate physical activity intervention experimental group
about 60 subjects in the control group who will participate in group cultural activities active comparison group
Assessment the assessment will include socio-demographic variables variables of psychophysical wellbeing cognitive variables variables related to physical health biomechanical variables assessment of skin integrity lab tests on blood samples
Times of evaluations both groups will be subjected to the measurements of the present study according to the following schedule
T0 baseline before the start of the intervention
T1 12 weeks after T0 at the end of the intervention
T2 after 20 weeks from T0 follow up 1
T3 48 weeks after T0 follow-up 2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None