Active Ageing and Health

Quality of Life Clinical Trial

Official title:

Active Ageing and Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858114
• Other study ID #: PG/2018/15546
• Status: Completed
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: November 8, 2020

Study information

• Verified date: November 2020
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 8, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

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

Intervention

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: warm up (10 minutes), up to 40% of HRR, with slow, dynamic movements and stretching for principal muscular groups; 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; 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.

Locations

Country	Name	City	State
Italy	Centro Obesità, AOU Cagliari	Cagliari
Italy	Clinica Dermatologica, AOU Cagliari	Cagliari
Italy	P.O. San Giovanni di Dio, AOU Cagliari	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (15)

Caronni A, Sterpi I, Antoniotti P, Aristidou E, Nicolaci F, Picardi M, Pintavalle G, Redaelli V, Achille G, Sciumè L, Corbo M. Criterion validity of the instrumented Timed Up and Go test: A partial least square regression study. Gait Posture. 2018 Mar;61: — View Citation

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 — View Citation

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. 20 — View Citation

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. Review. — View Citation

Dittmar M. Comparison of bipolar and tetrapolar impedance techniques for assessing fat mass. Am J Hum Biol. 2004 Sep-Oct;16(5):593-7. — View Citation

Hagströmer M, Oja P, Sjöström M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. — View Citation

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: 10.217 — View Citation

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. — View Citation

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. — View Citation

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: 1 — View Citation

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. — View Citation

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: 10.2174/17 — View Citation

Paillard T, Pau M, Noé F, González LM. Rehabilitation and Improvement of the Postural Function. Biomed Res Int. 2015;2015:703679. doi: 10.1155/2015/703679. Epub 2015 Nov 12. — View Citation

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 — View Citation

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 S — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (T0), and change from baseline at twelve (T1) weeks from baseline.
Primary	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).	Baseline (T0), and change from baseline at twenty (T2) weeks from baseline.
Primary	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).	Baseline (T0), and change from baseline at forty-eight (T3) weeks from baseline.
Primary	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)	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Primary	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)	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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).	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	Change in anthropometric measurements: waist circumference	effect of a light-to-moderate physical activity intervention on waist circumference, measured in centimeters.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Secondary	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).	Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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).	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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).	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	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.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary	Change in skin integrity	effect of a light-to-moderate physical activity intervention on skin integrity, measured by videodermoscopy.	Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.