NCT01705912

Brief Summary

The purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls. Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control. The training program was individually designed by a physiotherapist and the 5-month program performance was supervised in the partcipants home by eight home visits from an assistant nurse. All participants received a visit from an occupational therapist who assessed the home and, if necessary, gave advice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

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

January 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

2.9 years

First QC Date

October 9, 2012

Last Update Submit

October 11, 2012

Conditions

Keywords

fallprevention

Outcome Measures

Primary Outcomes (1)

  • Number of days with fall

    Self reported calendar data

    12 months

Secondary Outcomes (1)

  • Exercise

    12 months

Other Outcomes (11)

  • Strength

    Pre and post intervention, 5 months

  • Balance

    Pre and post intervention, 5 months

  • Balance

    Pre and post intervention, 5 months

  • +8 more other outcomes

Study Arms (2)

Training

EXPERIMENTAL

Complete intervention i.e. basic intervention + individual training program.

Other: Complete intervention

Control

ACTIVE COMPARATOR

Basic intervention.

Other: Basic intervention

Interventions

The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.

Training

The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.

Control

Eligibility Criteria

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

You may qualify if:

  • community living persons at least 65 years old
  • independent walking ability with or without walking aid
  • experienced at least one fall during the last 12 months
  • ability to communicate and cooperate with study staff

You may not qualify if:

  • ongoing physiotherapy treatment
  • ongoing participation in exercise/acitivity containing balance and strength enhancing components
  • a dementia diagnose
  • mental disorder that affects possibility to communicate and cooperate
  • other medical reason making participation inte the study inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family medicine research center

Örebro, 701 16, Sweden

Location

Study Officials

  • Gunilla Fahlstrom, PhD

    Örebro County Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations