NCT00623532

Brief Summary

Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly. The investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
Last Updated

May 19, 2009

Status Verified

May 1, 2009

First QC Date

February 15, 2008

Last Update Submit

May 18, 2009

Conditions

AgingFrailty

Keywords

Tertiary prevention of disability

Outcome Measures

Primary Outcomes (1)

  • MOS SF-12

Secondary Outcomes (1)

  • Timed Up and Go test

Study Arms (3)

CA

EXPERIMENTAL

Cognition and action are an inseparable whole while functioning, a new intervention based approach using familiarity based movements and non judgmental approach was labeled "cognition-action".

Behavioral: Mind-body exercises

AT

ACTIVE COMPARATOR

Adapted Tai Chi is based on Tai Chi like movements

Behavioral: Adapted Tai-chi

C

NO INTERVENTION

Control

Interventions

Mind-body exercisesBEHAVIORAL
CA
Adapted Tai-chiBEHAVIORAL
AT

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 and older
  • Institutionalized
  • Ability to get up alone or with technical or human help if necessary and ability to understand basic motor commands
  • Have given a signed consent

You may not qualify if:

  • Terminally ill and bedridden patients
  • Unable or unwilling to sign the consent
  • Have participated in a study in the past 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Xavier Arnozan, CHU de Bordeaux

Bordeaux, Gironde, 33604, France

Location

Related Publications (1)

  • Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.

    PMID: 20101011DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

May 1, 2006

Study Completion

February 1, 2008

Last Updated

May 19, 2009

Record last verified: 2009-05

Locations

FR(1)