NCT01247636

Brief Summary

The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

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, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
Last Updated

November 24, 2010

Status Verified

January 1, 2005

Enrollment Period

2 years

First QC Date

November 18, 2010

Last Update Submit

November 23, 2010

Conditions

Keywords

HLRQElderlyBalanceMobilityFear of falling

Outcome Measures

Primary Outcomes (2)

  • Health-related quality of life

    by the time of discharge mean 2 weeks after admission

  • Health-related quality of life

    3 months

Secondary Outcomes (3)

  • Functional balance (Berg Balance Scale)

    by the time of discharge mean 2 weeks after admission and after 3 months

  • Functional mobility

    by the time of discharge mean 2 weeks after admission, and after 3 months

  • Functional strength

    by the time of discharge mean 2 weeks after admission and after 3 months

Study Arms (1)

Home-exercise

EXPERIMENTAL
Other: Balance- training and home-exerciseOther: Balance-training and home-exercise

Interventions

Balance-training admitted at the geriatric hospital Home-exercise or advice to be generally active

Also known as: 1 intervention group, 1 control group
Home-exercise

The aim of the intervention was to enhance health-related quality of life, self-efficacy and physical function through education and exercise. The education program consisted of information given both oral and in writing regarding the benefits of physical activity. The aim was to increase the participants knowledge about the benefits of physical activity and to stimulate them to integrate physical activity into their immediate environment during daily routines. They were given an exercise-log and were advised to write down all their daily activities and exercise. The exercise program were conducted 2 times per week for 45 min per session. The content of these sessions were balance training with main focus on balance-exercises considered essential for daily living.

Also known as: 1 home-exercise group, 1 activity group
Home-exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • home-dwelling patients who were admitted at the geriatric clinic.
  • Assessed by a doctor to tolerate training
  • Able to walk in the corridor for 3 min with or without assistive device

You may not qualify if:

  • Cognitive disorders mini mental status \< 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital

Oslo, Oslo County, Norway

Location

Study Officials

  • Astrid Bergland, Professor

    No afflication

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 24, 2010

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 24, 2010

Record last verified: 2005-01

Locations