Clinical trial NCT01966562: PAHA Study: Psychological Active and Healthy Ageing
Official title: Psychological Well Being, Proactive Attitude and Happiness Effects of Whole-body Vibration vs. Multi-component Training in Aged Women: a Randomized Controlled-trial Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Lead sponsor: University of Bergamo
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 69
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The PAHA study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT is to compare the effectiveness of the WHOLE-BODY VIBRATION (WBV) with the Multi-component training control group and control group (CG) for psychological well being, quality of life, proactive attitude and happiness in female aged subjects.

Detailed description: A recent review has moreover suggested that the content (the mental and physical demand or challenge, and the behavioral aspects of the activity) and the context (the social context) of activities are key elements when distinguishing various types. Social activity affects wellbeing or survival by reducing the risks of social isolation and by supplying emotional intimacy, socio-emotional support, reinforcement for one's self-concept and social roles, and the sense of being valued. On the other hand, productive activity may influence health and wellbeing through satisfaction with outcomes, economic gains, mental stimulation, comforting personal routines, sense of purpose, and increased self-efficacy or self-esteem. There are significant relationships between QoL and attitudes toward aging in older adults. It has been in fact demonstrated that a proactive attitude (i.e., exercise, planning ahead, and marshaling support) influences QoL outcomes (i.e., depressive symptomatology and social activities).

Evidence has moreover shown that exist gender differences in engage physical activities and in mood state in ageing. In fact, aged women are less engaged in physical activity than men, probably due to menopausal transition (MT) state. Literature has suggested that women who experience longer MT and increased symptoms have higher stress and increased risk of depression , that in turn may affect their engagement in physical activities.

Starting from current literature, we hypothesize that specific physical activity, WBV, may promote psychological well being and quality of life in female aged subjects. Moreover and therefore, we assume an improvement in proactive attitude and happiness when compared to and Multi-component training control group.

Eligibility criteria: Inclusion Criteria:

* Women;
* Age ranged between 55-75 years old.

Exclusion Criteria:

* Male sex;
* Age lower than 55 years old;
* Present levels of DMO lower than 70 g/cm2;
* Being treated for a disease that can affect bone structure or neuromuscular system;
* Have orthopedic prosthetic implants in the lower limbs and / or spine; Have herniated discs;
* Suffer ocular diseases that affect the retina;
* Suffer severe cardiovascular diseases;
* Have a pacemaker, or osteosynthesis material;
* Severe mental illness (active psychosis/suicide risk/severe dementia);
* Linguistic limitations (such as stuttering/untreated audio impairment);
* A significant functional problem (such as unconsciousness/connection to respiration device/confinement to a wheelchair or bed/severe walking disability/need of help with basic daily activities), major depression, anxiety according to DSM-IV criteria.

Primary outcomes:
measure: Psychological General Well-Being Index (PGWBI)
timeFrame: Within one year after the treatment
Secondary outcomes:
measure: Subjective Happiness Scale (SHS)
timeFrame: Within one year after the treatment
measure: Proactive Attitude Scale (PA)
timeFrame: Within one year after the treatment
measure: SF-12 Health Survey
timeFrame: Within one year after the treatment
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: University of Bergamo
Study officials:
affiliation: University of Bergamo
name: Angelo Compare, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marin-Cascales E, Rubio-Arias JA, Alcaraz PE. Effects of Two Different Neuromuscular Training Protocols on Regional Bone Mass in Postmenopausal Women: A Randomized Controlled Trial. Front Physiol. 2019 Jul 10;10:846. doi: 10.3389/fphys.2019.00846. eCollection 2019.
citation: Compare A, Zarbo C, Marin E, Meloni A, Rubio-Arias JA, Berengui R, Grossi E, Shonin E, Martini G, Alcaraz PE. PAHA study: psychological active and healthy aging: psychological wellbeing, proactive attitude and happiness effects of whole-body vibration versus Multicomponent Training in aged women: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:177. doi: 10.1186/1745-6215-15-177.