ACTLIFE: is Active Life-style Enough?

NCT04877938 | Unknown

• 1 other identifier: PRIN 2017
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Sedentary lifestyles in modern obesogenic society produce several dysfunctions that cause chronic diseases in lederly population and this phenomenon is becoming a major public health problem. Regular physical activity has a profound effect on the expression of the potentials of human resilience, resulting in a decreased risk of chronic diseases. The identification of the biological mechanisms that are candidates for exercise-induced health benefits through biological pathways that are largely different from those targeted by common drugs, is highly relevant, since it might help to improve our knowledge of the pathophysiology of the chronic diseases in the sedentary population as well as to maximize the efficacy of physical activity interventions by implementing the best possible exercise dosage in older adults. For this purpose, the first aim of this project will be to identify the bioactive molecules and functional mechanisms that are candidates for exercise-induced health benefits. Moreover, in the view of more reliable, ecological and tailored approaches to counteract the problem of sedentary lifestyle, the second aim of this project will be to evaluate the effectiveness of an ecological exercise intervention in comparison to a traditional exercise intervention in sedentary elderly individuals.

Conditions

Sedentary Behavior

Keywords

Physical Activity; Echological Intevention; Older Adults

Outcome Measures

Primary Outcomes (1)

• Measure of strandars healthy-related biochemical parameters

  Blood samples will be collected two times: 1) between 7:00 and 9:00 am, following overnight fasting, 48h distant from the last exercise session and 2) immediately after a training session. After centrifugation, they will be divided in different aliquots of appropriate amount and stored a -80°C in order to: measure triglycerides, total cholesterol, blood glucose, aspartate transaminase, alanine transaminase, creatinine

  through study completion, an average of 8 months

Secondary Outcomes (9)

• Measure of Daily Energy Expenditure

  through study completion, an average of 8 months

• Measure of the appendicular muscle mass

  through study completion, an average of 8 months

• Measure of Musle architecture

  through study completion, an average of 8 months

• Measure of systemic vascular function

  through study completion, an average of 8 months

• Measure of cirulating level of hormones

  through study completion, an average of 8 months

Study Arms (3)

Echological Intervention

EXPERIMENTAL

A starting point for this 'Ecological-Exercise-Intervention'(EEI), would be to limit sitting time to no more than 2 hours/day, and to stand up and move after 30 minutes of continuous sitting. In accordance with several epidemiologic evidences light-intensity activities would be encouraged to substitute sedentary time (e.g., standing up while talking on the telephone, ironing while watching TV). Taking into consideration the guidance provided by ecologic models of health behavior evidences about specific constructs to guide EEI may be derived from behavioral research on physical activity.

Behavioral: Echolgical physical activity Intervention

Standard Physical Activity Intervention

ACTIVE COMPARATOR

People included in this group will be assigned to a standard physical activity program that will follow the guidelines of the American College of Sport and Medicine. The program will include moderate intensity aerobic and strength training, three times a week for a total amunt of 200 min of physical activity/week.

Behavioral: Echolgical physical activity Intervention

Control group

NO INTERVENTION

Individuals included in this group will be asked to keep their life style,without taking part in any physical activity program.

Interventions

Echolgical physical activity Intervention BEHAVIORAL

'Ecological-Exercise-Intervention'(EEI), would be to limit sitting time to no more than 2 hours/day, and to stand up and move after 30 minutes of continuous sitting. In accordance with several epidemiologic evidences light-intensity activities would be encouraged to substitute sedentary time (e.g., standing up while talking on the telephone, ironing while watching TV).

Echological Intervention; Standard Physical Activity Intervention

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• for sedentary individuals: ≤700 METs/week measured by IPAQ
• for active individuals: ≥1000 METs/week measured by IPAQ

You may not qualify if:

• Presence of cardiovascular and respiratory diseases
• Presence of Hypertension
• Presence of neurodegenerative diseases
• Pesence of acuteor chronic conditions that might influence inlfammatory response
• Any vascular Diabetes-related complication
• Drugs or alchol abuse
• Presence of other health-related condition that might affect the practice of physical activity.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, 37129, Italy

Location

Related Publications (1)

• Fiuza-Luces C, Garatachea N, Berger NA & Lucia A. (2013). Exercise is the real polypill. Physiology (Bethesda) 28, 330-358. Gilson ND, Ainsworth B, Biddle S, Faulkner G, Murphy MH, Niven A, Pringle A, Puig-Ribera A, Stathi A & Umstattd MR. (2009a). A multi-site comparison of environmental characteristics to support workplace walking. Prev Med 49, 21-23. Gilson ND, Puig-Ribera A, McKenna J, Brown WJ, Burton NW & Cooke CB. (2009b). Do walking strategies to increase physical activity reduce reported sitting in workplaces: a randomized control trial. Int J Behav Nutr Phys Act 6, 43. Iyer A, Fairlie DP, Prins JB, Hammock BD & Brown L. (2010). Inflammatory lipid mediators in adipocyte function and obesity. Nat Rev Endocrinol 6, 71-82. Joyner MJ & Green DJ. (2009). Exercise protects the cardiovascular system: effects beyond traditional risk factors. J Physiol 587, 5551-5558. Knaepen K, Goekint M, Heyman EM & Meeusen R. (2010). Neuroplasticity - exercise-induced response of peripheral brain-derived neurotrophic factor: a systematic review of experimental studies in human subjects. Sports Med 40, 765-801. Louis E, Raue U, Yang Y, Jemiolo B & Trappe S. (2007). Time course of proteolytic, cytokine, and myostatin gene expression after acute exercise in human skeletal muscle. J Appl Physiol (1985) 103, 1744-1751. Matthews CE, George SM, Moore SC, Bowles HR, Blair A, Park Y, Troiano RP, Hollenbeck A & Schatzkin A. (2012). Amount of time spent in sedentary behaviors and cause-specific mortality in US adults. Am J Clin Nutr 95, 437-445. Owen N, Sugiyama T, Eakin EE, Gardiner PA, Tremblay MS & Sallis JF. (2011). Adults' sedentary behavior determinants and interventions. Am J Prev Med 41, 189-196. Riechman SE, Balasekaran G, Roth SM & Ferrell RE. (2004). Association of interleukin-15 protein and interleukin-15 receptor genetic variation with resistance exercise training responses. J Appl Physiol (1985) 97, 2214-2219. Sallis JF, Cervero RB, Ascher W, Henderson KA, Kraft MK & Kerr J. (2006). An ecological approach to creating active living communities. Annu Rev Public Health 27, 297-322. Venturelli M, Pedrinolla A, Boscolo Galazzo I, Fonte C, Smania N, Tamburin S, Muti E, Crispoltoni L, Stabile A, Pistilli A, Rende M, Pizzini FB & Schena F. (2018). Impact of Nitric Oxide Bioavailability on the Progressive Cerebral and Peripheral Circulatory Impairments During Aging and Alzheimer's Disease. Frontiers in Physiology 9. Wald NJ & Law MR. (2003). A strategy to reduce cardiovascular disease by more than 80%. BMJ 326, 1419. Walther C, Gaede L, Adams V, Gelbrich G, Leichtle A, Erbs S, Sonnabend M, Fikenzer K, Korner A, Kiess W, Bruegel M, Thiery J & Schuler G. (2009). Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial. Circulation 120, 2251-2259.

  BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Federico Schena, PhD

CONTACT

0458415143; federico.schena@univr.it

Massimo Venturelli, PhD

CONTACT

0458425144; massimo.venturelli@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be awared of he group they belong. However, Invesitgators and Outcome assessors will not know the group each single participant belogns to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1 group echological intervention 1 group standard physical activity intervention 1 control group

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: May 7, 2021
• Study Start: June 20, 2021
• Primary Completion: June 30, 2022
• Study Completion: February 28, 2023
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)