AgedPAHANCT01966562
PAHA Study: Psychological Active and Healthy Ageing
A study testing WHOLE-BODY VIBRATION TRAINING and MULTICOMPONENT TRAINING in people with Aged, run by University of Bergamo at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Aged
- What is being tested?
- WHOLE-BODY VIBRATION TRAINING and MULTICOMPONENT TRAINING
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women;
- Age ranged between 55-75 years old.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Aged
- Being tested
- WHOLE-BODY VIBRATION TRAINING, MULTICOMPONENT TRAINING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOLE-BODY VIBRATION TRAININGBehavioural
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 TRAININGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WBV TRAINING | Experimental | WHOLE-BODY VIBRATION TRAINING Receives: Behavioral: WHOLE-BODY VIBRATION TRAINING |
| MC TRAINING | Active comparator | MULTICOMPONENT TRAINING Receives: Behavioral: MULTICOMPONENT TRAINING |
| CG | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within one year after the treatment
Secondary outcomes (3)
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).
Measured: Within one year after the treatment
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)
Measured: Within one year after the treatment
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).
Measured: Within one year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Compare, University of Bergamo
- Investigators
- Angelo Compare, Ph.D., Principal investigator, University of Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966562
- Sponsor's protocol ID
- NCT002899231
- Acronym
- PAHA
- Status last verified
- Sep 2013
- First submitted
- 8 Oct 2013
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31354513Compare 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.
PubMed 24886107
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01966562
- Acronym / sponsor ID
- PAHA / NCT002899231
- Conditions
- Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of BergamoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WBV TRAINING | Experimental | Behavioral: WHOLE-BODY VIBRATION TRAININGWHOLE-BODY VIBRATION TRAINING |
| MC TRAINING | Active comparator | Behavioral: MULTICOMPONENT TRAININGMULTICOMPONENT TRAINING |
| CG | No intervention | –Control group |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women;
- Age ranged between 55-75 years old.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOLE-BODY VIBRATION TRAININGThe 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). | Behavioural | WBV TRAINING |
| MULTICOMPONENT TRAININGThis 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. | Behavioural | MC TRAINING |
Primary outcome
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).
3 secondary outcomes
Subjective Happiness Scale (SHS)
Time frame: Within one year after the treatment
Proactive Attitude Scale (PA)
Time frame: Within one year after the treatment
SF-12 Health Survey
Time frame: Within one year after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
- Derived from this study: PubMed 31354513Marin-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.
- Derived from this study: PubMed 24886107Compare 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Compare, Ph.D. principal investigator
University of Bergamo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHOLE-BODY VIBRATION TRAINING and MULTICOMPONENT TRAINING in people with Aged, run by University of Bergamo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological General Well-Being Index (PGWBI) (time frame: Within one year after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01966562, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.