Clinical trial NCT03858114: Active Ageing and Health
Official title: Active Ageing and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Chronic Disease
Cognitive Decline
Quality of Life
Physical Activity
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Short Form Health Survey 12-items (SF-12) score at 12 weeks.
timeFrame: Baseline (T0), and change from baseline at twelve (T1) weeks from baseline.
measure: Change from baseline Short Form Health Survey 12-items (SF-12) score at 20 weeks.
timeFrame: Baseline (T0), and change from baseline at twenty (T2) weeks from baseline.
measure: Change from baseline Short Form Health Survey 12-items (SF-12) score at 48 weeks.
timeFrame: Baseline (T0), and change from baseline at forty-eight (T3) weeks from baseline.
measure: Change in gait speed measured using inertial sensor
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in functional balance measured using inertial sensor
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Secondary outcomes:
measure: Change in anthropometric measurements: BMI
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in anthropometric measurements: waist circumference
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in body composition
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in cognitive status.
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in inflammatory status: blood cells count.
timeFrame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
measure: Change in inflammatory status: erythrocyte sedimentation rate.
timeFrame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
measure: Change in inflammatory status: C-reactive proteine.
timeFrame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
measure: Change in metabolic status: basal glycaemia.
timeFrame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
measure: Change in metabolic status: blood lipids.
timeFrame: Baseline (T0), and change from baseline at twelve (T1) and twenty (T2) weeks from baseline.
measure: Change in psychological wellbeing
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in social rhythms
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in disability perception
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in pain perception
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in wrinkles severity
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
measure: Change in skin integrity
timeFrame: Baseline (T0), and change from baseline at twelve (T1), twenty (T2), and forty-eight (T3) weeks from baseline.
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Centro Obesità, AOU Cagliari
city: Cagliari
country: Italy
facility: Clinica Dermatologica, AOU Cagliari
city: Cagliari
country: Italy
facility: P.O. San Giovanni di Dio, AOU Cagliari
Study officials:
affiliation: University of Cagliari
name: Mauro Giovanni Carta, MD
role: PRINCIPAL_INVESTIGATOR
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