Study Results
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Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2019-02-28
2020-11-08
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Mild-to-moderate physical activity
Three sessions/week, for 12 weeks, of mild-to-moderate physical activity, of mixed type (aerobic-anaerobic), supervised by expert and qualified personnel (physical education instructors) and performed in a gym.
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.
Cultural group program
Cultural group program with thematic meetings and one visit/week to places of historical and artistic interest in the city of Cagliari, Sardinia, accompanied by expert guides (accredited tour guides).
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* certificate of fitness for non-competitive physical activity issued by a specialist in Sports Medicine.
Exclusion Criteria
* severe cardiovascular disease, such as myocardial infarction in the previous 2 years, aorto-coronary bypass, pacemaker or mechanical valvular prosthesis, aortic stenosis, acute pericarditis, acute myocarditis, aneurysms, angina, arrhythmias, moderate or severe aortic and mitral valve failure, arterial pressure at rest: systolic\> 200 mmHg, or diastolic\> 100 mmHg, pharmacologically non-compensated chronic atrial fibrillation, treatment with oral anticoagulants, thrombophlebitis or pulmonary embolism in the previous 2 years, ongoing moderate/severe anemia (Hb \<10 mg / dL);
* serious problems of autonomous walking, such as fractures of the lower limbs in the previous 2 years, upper limb fractures in the previous 6 months, surgical interventions (non-arthroscopic) in the joints in the previous 2 years, any reason of absolute immobility for more than a week in the previous two months, and for more than two weeks in the previous 6 months, severe osteoporosis, walking problems (eg, use of crutches or stick);
* severe metabolic disorders, such as insulin-treated diabetes mellitus or with HbA1c \> 8, or pharmacologically non-compensated thyreopathies (hyper/hypothyroidism);
* severe neurological conditions that determine the impossibility to carry out the physical activity protocol, such as stroke cerebri in the previous 2 years, or Parkinson's disease;
* severe bronchopulmonary disorders, such as severe bronchial asthma, severe chronic obstructive pulmonary disease, or pulmonary emphysema;
* severe renal disorders and make dialysis;
* severe glaucoma or retinal detachment in the previous 3 months;
* malignant neoplasm in progress, or in the previous 2 years.
65 Years
ALL
Yes
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Mauro Giovanni Carta
Professor
Principal Investigators
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Mauro Giovanni Carta, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cagliari
Locations
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Centro Obesità, AOU Cagliari
Cagliari, , Italy
Clinica Dermatologica, AOU Cagliari
Cagliari, , Italy
P.O. San Giovanni di Dio, AOU Cagliari
Cagliari, , Italy
Countries
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References
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Carta MG, Hardoy MC, Pilu A, Sorba M, Floris AL, Mannu FA, Baum A, Cappai A, Velluti C, Salvi M. Improving physical quality of life with group physical activity in the adjunctive treatment of major depressive disorder. Clin Pract Epidemiol Ment Health. 2008 Jan 26;4:1. doi: 10.1186/1745-0179-4-1.
Mura G, Carta MG. Physical activity in depressed elderly. A systematic review. Clin Pract Epidemiol Ment Health. 2013 Jul 12;9:125-35. doi: 10.2174/1745017901309010125. eCollection 2013.
Codella R, Luzi L, Inverardi L, Ricordi C. The anti-inflammatory effects of exercise in the syndromic thread of diabetes and autoimmunity. Eur Rev Med Pharmacol Sci. 2015 Oct;19(19):3709-22.
Rimland JM, Abraha I, Dell'Aquila G, Cruz-Jentoft A, Soiza R, Gudmusson A, Petrovic M, O'Mahony D, Todd C, Cherubini A. Effectiveness of Non-Pharmacological Interventions to Prevent Falls in Older People: A Systematic Overview. The SENATOR Project ONTOP Series. PLoS One. 2016 Aug 25;11(8):e0161579. doi: 10.1371/journal.pone.0161579. eCollection 2016.
Helmich I, Latini A, Sigwalt A, Carta MG, Machado S, Velasques B, Ribeiro P, Budde H. Neurobiological alterations induced by exercise and their impact on depressive disorders [corrected]. Clin Pract Epidemiol Ment Health. 2010 Nov 30;6:115-25. doi: 10.2174/1745017901006010115.
Mura G, Cossu G, Migliaccio GM, Atzori C, Nardi AE, Machado S, Carta MG. Quality of life, cortisol blood levels and exercise in older adults: results of a randomized controlled trial. Clin Pract Epidemiol Ment Health. 2014 Jun 13;10:67-72. doi: 10.2174/1745017901410010067. eCollection 2014.
Margraf J, Lavallee K, Zhang X, Schneider S. Social Rhythm and Mental Health: A Cross-Cultural Comparison. PLoS One. 2016 Mar 8;11(3):e0150312. doi: 10.1371/journal.pone.0150312. eCollection 2016.
Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Pigliautile M, Ricci M, Mioshi E, Ercolani S, Mangialasche F, Monastero R, Croce MF, Federici S, Mecocci P. Validation study of the Italian Addenbrooke's Cognitive Examination Revised in a young-old and old-old population. Dement Geriatr Cogn Disord. 2011;32(5):301-7. doi: 10.1159/000334657. Epub 2012 Jan 19.
Monticone M, Baiardi P, Nava T, Rocca B, Foti C. The Italian version of the Sickness Impact Profile-Roland Scale for chronic pain: cross-cultural adaptation, reliability, validity and sensitivity to change. Disabil Rehabil. 2011;33(15-16):1299-305. doi: 10.3109/09638288.2010.527030. Epub 2010 Oct 29.
Dittmar M. Comparison of bipolar and tetrapolar impedance techniques for assessing fat mass. Am J Hum Biol. 2004 Sep-Oct;16(5):593-7. doi: 10.1002/ajhb.20066.
Paillard T, Pau M, Noe F, Gonzalez LM. Rehabilitation and Improvement of the Postural Function. Biomed Res Int. 2015;2015:703679. doi: 10.1155/2015/703679. Epub 2015 Nov 12. No abstract available.
Caronni A, Sterpi I, Antoniotti P, Aristidou E, Nicolaci F, Picardi M, Pintavalle G, Redaelli V, Achille G, Sciume L, Corbo M. Criterion validity of the instrumented Timed Up and Go test: A partial least square regression study. Gait Posture. 2018 Mar;61:287-293. doi: 10.1016/j.gaitpost.2018.01.015. Epub 2018 Jan 31.
Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated grading scale for forehead lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S155-60. doi: 10.1111/j.1524-4725.2008.34364.x.
Cossu G, Atzeni M, Cantone E, Forte V, Tusconi M, Kalcev G, Maleci A, Montisci R, Ferreli C, Atzori L, Primavera D, Dursun SM, Bert F, Tramontano E, Carta MG. Resilience to depression and unchanged quality of life in Sardinian old adults during COVID-19 lockdown. Front Psychiatry. 2025 Sep 3;16:1642413. doi: 10.3389/fpsyt.2025.1642413. eCollection 2025.
Carta MG, Cossu G, Pintus E, Zaccheddu R, Callia O, Conti G, Pintus M, Aviles Gonzalez CI, Massidda MV, Mura G, Sardu C, Contu P, Minerba L, Demontis R, Pau M, Finco G, Cocco E, Penna MP, Orr G, Kalcev G, Cabras F, Lorrai S, Loviselli A, Velluzzi F, Monticone M, Cacace E, Musu M, Rongioletti F, Cauli A, Ruggiero V, Scano A, Crisafulli A, Cosentino S, Atzori L, Massa E, Mela Q, Fortin D, Migliaccio G, Machado S, Romano F, Preti A. Moderate Exercise Improves Cognitive Function in Healthy Elderly People: Results of a Randomized Controlled Trial. Clin Pract Epidemiol Ment Health. 2021 Sep 16;17:75-80. doi: 10.2174/1745017902117010075. eCollection 2021.
Carta MG, Cossu G, Pintus E, Zoccheddu R, Callia O, Conti G, Pintus M, Gonzalez CIA, Massidda MV, Mura G, Sardu C, Contu P, Minerba L, Demontis R, Pau M, Finco G, Cocco E, Penna MP, Orru G, Kalcev G, Cabras F, Lorrai S, Loviselli A, Velluzzi F, Monticone M, Cacace E, Musu M, Rongioletti F, Cauli A, Ruggiero V, Scano A, Crisafulli A, Cosentino S, Atzori L, Massa E, Mela Q, Fortin D, Migliaccio G, Nardi AE, Angermeyer M, Preti A. Active elderly and health-can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial. Trials. 2021 May 7;22(1):331. doi: 10.1186/s13063-021-05278-6.
Other Identifiers
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PG/2018/15546
Identifier Type: -
Identifier Source: org_study_id