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PAHA Study: Psychological Active and Healthy Ageing (PAHA)

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ClinicalTrials.gov Identifier: NCT01966562
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Angelo Compare, University of Bergamo

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.

Condition or disease Intervention/treatment Phase
Aged Behavioral: WHOLE-BODY VIBRATION TRAINING Behavioral: MULTICOMPONENT TRAINING Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : November 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: WBV TRAINING
WHOLE-BODY VIBRATION TRAINING
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).

Active Comparator: MC TRAINING
MULTICOMPONENT TRAINING
Behavioral: 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.

No Intervention: CG
Control group



Primary Outcome Measures :
  1. Psychological General Well-Being Index (PGWBI) [ Time Frame: Within one year after the treatment ]
    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).


Secondary Outcome Measures :
  1. Subjective Happiness Scale (SHS) [ Time Frame: Within one year after the treatment ]
    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).

  2. Proactive Attitude Scale (PA) [ Time Frame: Within one year after the treatment ]
    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)

  3. SF-12 Health Survey [ Time Frame: Within one year after the treatment ]
    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).



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966562


Locations
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Italy
University of Bergamo
Bergamo, Italy
Sponsors and Collaborators
University of Bergamo
Investigators
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Principal Investigator: Angelo Compare, Ph.D. University of Bergamo