NCT03858114

Active Ageing and Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Cagliari · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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).

Conditions

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

Interventions

Type	Name	Description
OTHER	Mild-to-moderate physical activity	According to ACSM guidelines, mild-to-moderate Physical Activity (PA) will be established as ≤ 60% of the Heart Rate Reserve (HRR). Baseline HR will be registered for all participants for three days, and the mean data will be utilized. PA intervention will consist of three phases: 1. warm up (10 minutes), up to 40% of HRR, with slow, dynamic movements and stretching for principal muscular groups; 2. Active phase (45 minutes), from \>40% to 60% HRR, with static and dynamic exercises for postural control and spine mobility, and balance exercises, with activation of core muscles; 3. cool down (10 minutes), \< 40% of HRR, with cardiorespiratory cool-down exercises followed by relaxation, and post-stretch exercises to return muscles to a pre-exercises length.
OTHER	Cultural group program	A cultural group program with 12-weeks thematic meetings on places of historical and artistic interest in the city of Cagliari, Sardinia, with one visit/week to the same sites. The participants will be accompanied by expert tour guides to museums, monuments, city parks and archeological sites.

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-02-26
• Completion: 2020-11-08
• First posted: 2019-02-28
• Last updated: 2020-11-10

Locations

3 sites across 1 country: Italy