Active Ageing and Health

Quality of Life Clinical Trial

Official title: Active Ageing and Health

Status Completed

Clinical Trial 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 (treatment/control) with ratio of 1:1, 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Aging
• Chronic Disease
• Cognitive Decline
• Cognitive Dysfunction
• Physical Activity
• Quality of Life

• NCT number: NCT03858114
• Study type: Interventional
• Source: University of Cagliari
• Status: Completed
• Phase: N/A
• Start date: February 28, 2019
• Completion date: November 8, 2020