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Fall Prevention for Old Community-dwelling People

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
karin hellstrom, Uppsala University
ClinicalTrials.gov Identifier:
NCT01778972
First received: January 16, 2013
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in community-dwelling people 75 years or older on frequence of falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life, mortality and health-related costs.


Condition Intervention
Physical Activity
Other: Otago home exercise programme
Other: Motivational interviewing plus Otago

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fall Prevention for Old Community-dwelling People in Uppsala, Västerås and Sörmland

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Frequence of falls will be measured with a monthly fall-calender [ Time Frame: Two year ] [ Designated as safety issue: No ]
    A fall-calender with registration of falls on a monthly bases will be used to record falls. The fall-calender should be sent in each month. Falls will be followed-up with telephone interviews.


Secondary Outcome Measures:
  • Fall-related injuries will be measured by telephone interviews. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Physical performance will be measured with Short Physical Performance Battery (SPPB) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    SPPB measures balance, functional leg strength and walking speed.

  • Dynamic balance will be assessed with Mini-BESTest [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Mini-BESTest assess dynamic balance impairments in 14 items. The items covers a broad spectrum of performance tasks, including transitions and anticipatory postural adjustments, postural responses to to perturbation, sensory orientation and dynamic stability in gait.


Other Outcome Measures:
  • Fall-related self-efficacy will be measured with Fall efficacy scale, Swedish version. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Grip strength will be measured with Jamar Hand Dynamometer [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Physical Activity level will be measured with Frändin/Grimby activity scale. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Health related quality of life will be measured with European quality of life questionaire (EQ-5D). [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Otago home training programme

Otago home exercise programme was designed specifically to prevent fall. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.

The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.

Other: Otago home exercise programme

Otago home exercise program was designed specifically to prevent falls. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.

The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.

Experimental: Motivational interviewing plus Otago
This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.
Other: Motivational interviewing plus Otago
This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.
No Intervention: Control grop
Participants are instructed to live their ordinary lives.

Detailed Description:

Participants in the two intervention groups will exercise at home with supervision from physiotherapist week one, two, four and eight. They will then be contacted for telephone follow-up month five, seven and twelve after the start of training. The control group is encouraged to live as usual.

All participants are assessed at baseline, after six, 12 and 24 months from inclusion in the study.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

75 years or older, community-dwelling, in need of homecare or rollator

Exclusion Criteria:

Cognitive impairment (below 25 on Mini Mental test) Not able to transfer independently indoors -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778972

Locations
Sweden
Homes Recruiting
Uppsala, Sweden
Contact: Susanna Tuvemo, PhD student    +46 18 471 47 73    susanna.tuvemo.johnson@neuro.uu.se   
Principal Investigator: Karin E Hellström, PhD         
Homes Recruiting
Västerås, Sweden
Contact: Ann-Christine Johansson, PhD    +46 21 17 58 87    ann-christine.johansson@mdh.se   
Principal Investigator: Ann-Christine Johansson, PhD         
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Karin E Hellström, PhD Uppsala University
Principal Investigator: Ann-Christin Johansson, PhD Mälardalens University, Sweden
Principal Investigator: Anne Söderlund, Professor Mälardalens University, Sweden
  More Information

No publications provided

Responsible Party: karin hellstrom, PhD, Senior Lecturer, Uppsala University
ClinicalTrials.gov Identifier: NCT01778972     History of Changes
Other Study ID Numbers: Fall prevention UV, 307301
Study First Received: January 16, 2013
Last Updated: January 25, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University:
Fall prevention
Home exercise
Strength training
Balance training

ClinicalTrials.gov processed this record on November 20, 2014