PAHA Study: Psychological Active and Healthy Ageing

Aged Clinical Trial

— PAHA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966562
• Other study ID #: NCT002899231
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: October 16, 2013
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: University of Bergamo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aged

Intervention

Behavioral:
• WHOLE-BODY VIBRATION TRAINING
The vibration stimulus consisted of uniform vertical oscillations Power Plate® Next Generation (Power Plate North America, Northbrook, IL, USA). Subjects stood on the platform holding an quarter squat positions with the feet shoulder-width apart. Then, they perform ankle extensions with the following work sequence (establishing a rhythm of 100 b.p.m.: 1 b.p.m for the concentric phase; and 5 b.p.m. for the eccentric phase). After the familiarization 2-weeks, subjects trained 3 days per week for 6-months (72 sessions) using a vibrating training program that began with 5 sets and a frequency of 35 Hz per session and increasing by 11 sets and 40 Hz frequency the last month maintaining a series of parameters: vibration amplitude (4 mm) working time (60 s) and recovery time (60 s).
• MULTICOMPONENT TRAINING
This training combined vertical jumps and high intensity walking. During the first month, small reactive vertical jumps (without knee and ankle flexion) were performed. After the first month, subjects performed drop jumps progressively starting at a height of 5 cm and finishing at 25 cm at the end of the programme (increases of 5 cm each month). Additionally, the sets were increased from 4x10 jumps to 6x10 each week, finishing the last week with 4x10. In this sense, the drop jumps were the same each month but the total load (imposed by height) increased progressively. Regarding the aerobic exercise, the load increased progressively along the 6 months. The intensity ranged between 50-75% of reserve heart rate, the volume ranged between 30-60 min.

Locations

Country	Name	City	State
Italy	University of Bergamo	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergamo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological General Well-Being Index (PGWBI)	The PGWBI. It is a self-administered test with 22 items that assess the subjective sensation of psychological wellbeing. It has been divided in 6 categories: anxiety, depression, self-control, positivity and wellbeing, health and vitality (Grossi et al., 2006).	Within one year after the treatment	Yes
Secondary	Subjective Happiness Scale (SHS)	It 4-item scale for assessing subjective happiness. Two items ask respondents to characterize themselves using both absolute ratings and ratings relative to peers, whereas the other two items offer brief descriptions of happy and unhappy individuals and ask respondents the extent to which each characterization describes them. The SHS has been validated in 14 studies with a total of 2,732 participants. Preliminary results have indicated that the SHS has high internal consistency, which has been found to be stable across samples. Test-retest and self-peer correlations have suggested good to excellent reliability, and construct validation studies of convergent and discriminant validity have confirmed the use of this scale to measure the construct of subjective happiness (Lyubomirsky & Lepper, 1999).	Within one year after the treatment	Yes
Secondary	Proactive Attitude Scale (PA)	It assess the presence of a Proactive Attitude that is a relatively persistent personal belief in the rich potential of changes that can be made to improve oneself and one's environment. The proactive attitude has implications for motivation and action. This includes various facets such as resourcefulness, responsibility, values and vision. The psychological construct of Proactive Attitude (PA) present a correlation of r = .56 with general self-efficacy (Schwarzer, 1999)	Within one year after the treatment	Yes
Secondary	SF-12 Health Survey	It is a self-administered test that assesses the global health status by the subjective point of view of the subject. It has been divided into two principal subscales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). In particular, it allows to asses concept concerning health, physical functions, pain, general health, vitality, social functioning, emotional functioning and mental health (Kodraliu et al., 2001).	Within one year after the treatment	Yes