AgingNCT03858114

Active Ageing and Health

A study testing Mild-to-moderate physical activity and Cultural group program in people with Aging and Chronic Disease, run by University of Cagliari at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Aging, Chronic Disease, Cognitive Decline
What is being tested?: Mild-to-moderate physical activity and Cultural group program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 3 sitesItaly
Study dates: 28 Feb 2019to 8 Nov 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

sedentary (do not practicing regular physical activity, at least 2 times a week, for at least 6 months).
certificate of fitness for non-competitive physical activity issued by a specialist in Sports Medicine.

Who cannot join

BMI (Body Mass Index)>35;
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;

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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.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

Centro Obesità, AOU Cagliari
Cagliari, 09100
Clinica Dermatologica, AOU Cagliari
Cagliari, 09100
P.O. San Giovanni di Dio, AOU Cagliari
Cagliari, 09100

Other trials in Italy

About this study

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
Being tested: Mild-to-moderate physical activity, Cultural group program
Medical subject headings: Chronic Disease, Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mild-to-moderate physical activityOther
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 programOther
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.

Study groups in NCT03858114
Study group	Role	What they receive
Mild-to-moderate physical activity	Experimental	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. Receives: Other: Mild-to-moderate physical activity
Cultural group program	Active comparator	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). Receives: Other: Cultural group program

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline Short Form Health Survey 12-items (SF-12) score at 12 weeks.
effect of a light-to-moderate physical activity intervention on Quality of Life, measured by the Short Form Health Survey 12-items (SF-12). SF-12 measures perceived Quality of Life, with higher scores corresponding to a better subjective perception of Quality of Life, and can be aggregated as Physical Component score (ranging from 6 to 18), Mental Component score (ranging from 6 to 25), and summed as Global Component score (ranging from 12 to 43).
Measured: Baseline (T0), and change from baseline at twelve (T1) weeks from baseline.
Change from baseline Short Form Health Survey 12-items (SF-12) score at 20 weeks.
effect of a light-to-moderate physical activity intervention on Quality of Life, measured by the Short Form Health Survey 12-items (SF-12). SF-12 measures perceived Quality of Life, with higher scores corresponding to a better subjective perception of Quality of Life, and can be aggregated as Physical Component score (ranging from 6 to 18), Mental Component score (ranging from 6 to 25), and summed as Global Component score (ranging from 12 to 43).
Measured: Baseline (T0), and change from baseline at twenty (T2) weeks from baseline.
Change from baseline Short Form Health Survey 12-items (SF-12) score at 48 weeks.
effect of a light-to-moderate physical activity intervention on Quality of Life, measured by the Short Form Health Survey 12-items (SF-12). SF-12 measures perceived Quality of Life, with higher scores corresponding to a better subjective perception of Quality of Life, and can be aggregated as Physical Component score (ranging from 6 to 18), Mental Component score (ranging from 6 to 25), and summed as Global Component score (ranging from 12 to 43).
Measured: Baseline (T0), and change from baseline at forty-eight (T3) weeks from baseline.
Change in gait speed measured using inertial sensor
effect of a light-to-moderate physical activity intervention on mobility, assessed by changes in gait speed measured using a single wearable inertial sensor located in the low back (L4-L5 vertebrae)
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in functional balance measured using inertial sensor
effect of a light-to-moderate physical activity intervention on functional balance, assessed by changes in time needed to complete a 3m Timed-up-and-go (TUG) test. This will be carried out using a single wearable inertial sensor located in the low back (L4-L5 vertebrae)
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.

Secondary outcomes (15)

Change in anthropometric measurements: BMI
effect of a light-to-moderate physical activity intervention on BMI (Body Mass Index), measured as the body weight divided by the square of the body height (kg/ m2).
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in anthropometric measurements: waist circumference
effect of a light-to-moderate physical activity intervention on waist circumference, measured in centimeters.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in body composition
effect of a light-to-moderate physical activity intervention on body composition (e.g. lean and fat mass, and total body water), measured by bioimpedentiometry.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in cognitive status.
effect of a light-to-moderate physical activity intervention on cognitive functions, assessed by the Addenbrooke's Cognitive Examination Revised (ACE-R), which contains 5 sub-scores, each one representing one cognitive domain: attention/orientation (18 points), memory (26 points), fluency (14 points), language (26 points) and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in inflammatory status: blood cells count.
effect of a light-to-moderate physical activity intervention on inflammatory status, measured by lab analyses (CBC + fl. + Plt), measured by blood cells count (e.g. erythrocytes count, total and differential leucocytes count, platelets count), measured as number of cells/microliter. The normal red blood cells (RBC) range for men is 4.7 to 6.1 million cells/mcL, for women is 4.2 to 5.4 million mcL. The normal white blood cells (WBCs) count ranges 5000-10000/mcL, with normal percentages of WBCs types as following: 55-73% neutrophils, 20-40% lymphocytes, 2-8% monocytes, 1-4% eosinophils, 0.5-1% basophils. The normal platelets count ranges 150000-450000/mcL.
Measured: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in inflammatory status: erythrocyte sedimentation rate.
effect of a light-to-moderate physical activity intervention on inflammatory status, measured by erythrocyte sedimentation rate (ESR). The normal range is 0-22 millimeters/hour for men and 0-29 millimeters/hour for women.
Measured: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in inflammatory status: C-reactive proteine.
effect of a light-to-moderate physical activity intervention on inflammatory status, measured by C-reactive proteine (CRP). Normal concentrations of CRP varies between 0.8 mg/L to 3.0 mg/L.
Measured: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in metabolic status: basal glycaemia.
effect of a light-to-moderate physical activity intervention on metabolic status, measured by basal glycaemia, ranging from 72 to 99 mg/dL.
Measured: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in metabolic status: blood lipids.
effect of a light-to-moderate physical activity intervention on metabolic status, measured as blood lipids concentration (mg/dL) for Total cholesterol (limit value: 199 mg/dL) , HDL cholesterol (normal value men: 41-59 mg/dL; normal value women: 51-60 mg/dL), Triglycerides (normal value: 150-199 mg/dL).
Measured: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in psychological wellbeing
effect of a light-to-moderate physical activity intervention on depressive/anxiety symptoms, assessed by the Patient Health Questionnaire-9 items (PHQ-9) questionnaire. The PHQ-9 ranges from 0 (no psychopathological symptoms, better score) to 27 (worse score), with minor depression cut-off for scores ≥5, and major depressive disorder cut-off scores ≥10.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in social rhythms
effect of a light-to-moderate physical activity intervention on social rhythms, assessed by the Brief Social Rhythms Scale (BSRS) questionnaire. The BSRS consists of ten items, assessing the general regularity with which interviewed engage in basic daily activities during the workweek and on the weekend, ranging from 1 (very regularly) to 6 (very irregularly), with high mean scores indicating high irregularity. Summary scores are the average across all 10 items.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in disability perception
effect of a light-to-moderate physical activity intervention on physical disability perception, measured by the Sickness Impact Profile-Roland (SIP-Roland) scale for disability. The SIP-Roland scale is a 23-items questionnaire with a total score ranging from 0 (better score, no disability) to 23 (worse score).
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in pain perception
effect of a light-to-moderate physical activity intervention on physical pain perception, measured by the NPRS (Numeric Pain Rating Scale). The NPRS is a visual-analogic scale rating the current pain perception, ranging from 0 (better score, no pain) to 10 (the worst pain imaginable).
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in wrinkles severity
effect of a light-to-moderate physical activity intervention on wrinkles severity, measured by Visual Wrinkles Scale, assessing the wrinkles grade ranging from 0 (no wrinkles) to 5 (very deep wrinkle, redundant fold) in the following anatomic points: horizontal forehead lines, glabellar frown lines, periorbital lines, preauricular lines, cheek lines, naso-labial folds, radial upper and lower lip lines, corner of the mouth lines, "marionette lines", labiomental crease, horizontal neck folds.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in skin integrity
effect of a light-to-moderate physical activity intervention on skin integrity, measured by videodermoscopy.
Measured: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 20198 Nov 2020

First posted28 Feb 2019
Study start28 Feb 2019
Primary completion26 Feb 2020
Study completion8 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for AgingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03858114
Sponsor's protocol ID: PG/2018/15546
Status last verified: Nov 2020
First submitted: 13 Feb 2019
Last updated: 10 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 18221549
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.
PubMed 24009640
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.
PubMed 26502862
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.
PubMed 27559744
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.
PubMed 21283646
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.
PubMed 25006344
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.
PubMed 26954568
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.
PubMed 16925881
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.
PubMed 11556941
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.
PubMed 22262124
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.
PubMed 21034202
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.
PubMed 15368607
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.
PubMed 26640793
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.
PubMed 29413799
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.
PubMed 19021673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Active Ageing and Health
ClinicalTrials.gov ID: NCT03858114
Acronym / sponsor ID: PG/2018/15546
Conditions: Aging, Chronic Disease, Cognitive Decline, Quality of Life, Physical Activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: University of CagliariUniversity, hospital or other
Study start: 28 Feb 2019 (actual)
Primary completion: 26 Feb 2020 (actual)
Study completion: 8 Nov 2020 (actual)
First posted: 28 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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).

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).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mild-to-moderate physical activity	Experimental	Other: Mild-to-moderate physical activityThree 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.
Cultural group program	Active comparator	Other: Cultural group programCultural 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).

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

sedentary (do not practicing regular physical activity, at least 2 times a week, for at least 6 months).
certificate of fitness for non-competitive physical activity issued by a specialist in Sports Medicine.

Key exclusion criteria (9 listed)

BMI (Body Mass Index)>35;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mild-to-moderate physical activityAccording 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	Mild-to-moderate physical activity
Cultural group programA 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.	Other	Cultural group program

Primary outcome

Change from baseline Short Form Health Survey 12-items (SF-12) score at 12 weeks.
Time frame: Baseline (T0), and change from baseline at twelve (T1) weeks from baseline.
effect of a light-to-moderate physical activity intervention on Quality of Life, measured by the Short Form Health Survey 12-items (SF-12). SF-12 measures perceived Quality of Life, with higher scores corresponding to a better subjective perception of Quality of Life, and can be aggregated as Physical Component score (ranging from 6 to 18), Mental Component score (ranging from 6 to 25), and summed as Global Component score (ranging from 12 to 43).
Change from baseline Short Form Health Survey 12-items (SF-12) score at 20 weeks.
Time frame: Baseline (T0), and change from baseline at twenty (T2) weeks from baseline.
effect of a light-to-moderate physical activity intervention on Quality of Life, measured by the Short Form Health Survey 12-items (SF-12). SF-12 measures perceived Quality of Life, with higher scores corresponding to a better subjective perception of Quality of Life, and can be aggregated as Physical Component score (ranging from 6 to 18), Mental Component score (ranging from 6 to 25), and summed as Global Component score (ranging from 12 to 43).
Change from baseline Short Form Health Survey 12-items (SF-12) score at 48 weeks.
Time frame: Baseline (T0), and change from baseline at forty-eight (T3) weeks from baseline.
effect of a light-to-moderate physical activity intervention on Quality of Life, measured by the Short Form Health Survey 12-items (SF-12). SF-12 measures perceived Quality of Life, with higher scores corresponding to a better subjective perception of Quality of Life, and can be aggregated as Physical Component score (ranging from 6 to 18), Mental Component score (ranging from 6 to 25), and summed as Global Component score (ranging from 12 to 43).
Change in gait speed measured using inertial sensor
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
effect of a light-to-moderate physical activity intervention on mobility, assessed by changes in gait speed measured using a single wearable inertial sensor located in the low back (L4-L5 vertebrae)
Change in functional balance measured using inertial sensor
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
effect of a light-to-moderate physical activity intervention on functional balance, assessed by changes in time needed to complete a 3m Timed-up-and-go (TUG) test. This will be carried out using a single wearable inertial sensor located in the low back (L4-L5 vertebrae)

15 secondary outcomes

Change in anthropometric measurements: BMI
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in anthropometric measurements: waist circumference
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in body composition
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in cognitive status.
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in inflammatory status: blood cells count.
Time frame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in inflammatory status: erythrocyte sedimentation rate.
Time frame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in inflammatory status: C-reactive proteine.
Time frame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in metabolic status: basal glycaemia.
Time frame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in metabolic status: blood lipids.
Time frame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Change in psychological wellbeing
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in social rhythms
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in disability perception
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in pain perception
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in wrinkles severity
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Change in skin integrity
Time frame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Results publication: PubMed 18221549Carta 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.
Results publication: PubMed 24009640Mura 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.
Results publication: PubMed 26502862Codella 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.
Results publication: PubMed 27559744Rimland 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.
Results publication: PubMed 21283646Helmich 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.
Results publication: PubMed 25006344Mura 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.
Results publication: PubMed 26954568Margraf 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.
Results publication: PubMed 16925881Hagstromer 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.
Results publication: PubMed 11556941Kroenke 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.
Results publication: PubMed 22262124Pigliautile 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.
Results publication: PubMed 21034202Monticone 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.
Results publication: PubMed 15368607Dittmar 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mauro Giovanni Carta, MD principal investigator

University of Cagliari

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mild-to-moderate physical activity and Cultural group program in people with Aging and Chronic Disease, run by University of Cagliari at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Short Form Health Survey 12-items (SF-12) score at 12 weeks. (time frame: Baseline (T0), and change from baseline at twelve (T1) weeks from baseline.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03858114, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.