PAHA Study: Psychological Active and Healthy Ageing

NCT01966562 | Completed

• 1 other identifier: NCT002899231
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Subjective Happiness Scale (SHS)

  Within one year after the treatment

• Proactive Attitude Scale (PA)

  Within one year after the treatment

• SF-12 Health Survey

  Within one year after the treatment

Study Arms (3)

WBV TRAINING

EXPERIMENTAL

WHOLE-BODY VIBRATION TRAINING

Behavioral: WHOLE-BODY VIBRATION TRAINING

MC TRAINING

ACTIVE COMPARATOR

MULTICOMPONENT TRAINING

Behavioral: MULTICOMPONENT TRAINING

CG

NO INTERVENTION

Control group

Interventions

WHOLE-BODY VIBRATION TRAINING BEHAVIORAL

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).

WBV TRAINING

MULTICOMPONENT TRAINING 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.

MC TRAINING

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bergamo: lead

Study Sites (1)

University of Bergamo

Bergamo, Italy

Location

Related Publications (2)

• 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.

  PMID: 31354513 DERIVED

• 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.

  PMID: 24886107 DERIVED

Study Officials

• Angelo Compare, Ph.D.

  University of Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 21, 2013
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2013
• Last Updated: October 21, 2013

Record last verified: 2013-09

Locations

IT (1)