PAHA Study: Psychological Active and Healthy Ageing

NCT ID: NCT01966562

Last Updated: 2013-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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

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Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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WBV TRAINING

WHOLE-BODY VIBRATION TRAINING

Group Type EXPERIMENTAL

WHOLE-BODY VIBRATION TRAINING

Intervention Type BEHAVIORAL

The vibration stimulus consisted of uniform vertical oscillations Power PlateĀ® 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).

MC TRAINING

MULTICOMPONENT TRAINING

Group Type ACTIVE_COMPARATOR

MULTICOMPONENT TRAINING

Intervention Type BEHAVIORAL

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.

CG

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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WHOLE-BODY VIBRATION TRAINING

The vibration stimulus consisted of uniform vertical oscillations Power PlateĀ® 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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Bergamo

OTHER

Sponsor Role lead

Responsible Party

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Angelo Compare

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelo Compare, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Bergamo

Locations

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University of Bergamo

Bergamo, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 31354513 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24886107 (View on PubMed)

Other Identifiers

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NCT002899231

Identifier Type: -

Identifier Source: org_study_id