NCT00218842

Brief Summary

As designs of existing outcome studies are disparate and do not always relate well to a Swedish context, the need for further studies is obvious. Also, an empirical theory drawn from the best practice supporting autonomy and wellbeing for clients in a nursing home setting has not yet been fully depicted. The study described below intends to fill a gap in knowledge related to the effect of enhanced activities of daily living (ADL)-training, physical, and daily activities and staff education in a nursing home setting, based on a theory- and evidence-based intervention programme in a Swedish as well as a Nordic health care context. The aims of the study are to describe the impact of an individually tailored intervention program, in a nursing home setting, on:

  • Physical capacity
  • Degree of dependence in ADL
  • Long-term participation in physical and/or daily activities
  • Self-rated wellbeing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

4 years

First QC Date

September 20, 2005

Last Update Submit

March 6, 2014

Conditions

FrailtyNursing Home Residents

Keywords

exercisefunctioningfrail elderly

Outcome Measures

Primary Outcomes (1)

  • Physical function

    baseline, three and six months

Secondary Outcomes (1)

  • Falls

    during six months

Study Arms (2)

exercise group

EXPERIMENTAL

individualized exercise

Behavioral: Individualized exercise

control group

NO INTERVENTION

care as usal

Interventions

Individualized exerciseBEHAVIORAL

individualized exercise, physical activity and training in daily life situations given by trained physical therapists and occupational therapists

exercise group

Eligibility Criteria

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

You may qualify if:

  • \> 65 years of age
  • Expected stay in the nursing home \> 3 months
  • Able to take instruction

You may not qualify if:

  • Persons in a terminal phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Geriatric Medicine, St. Olavs University Hospital

Trondheim, Trondheim, N-7016, Norway

Location

Related Publications (3)

  • Frandin K, Borell L, Gronstedt H, Bergland A, Helbostad JL, Puggaard L, Andresen M, Granbo R, Hellstrom K. A Nordic multi-center study on physical and daily activities for residents in nursing home settings: design of a randomized, controlled trial. Aging Clin Exp Res. 2009 Aug-Oct;21(4-5):314-22. doi: 10.1007/BF03324921.

    PMID: 19959920BACKGROUND

  • Gronstedt H, Hellstrom K, Bergland A, Helbostad JL, Puggaard L, Andresen M, Granbo R, Frandin K. Functional level, physical activity and wellbeing in nursing home residents in three Nordic countries. Aging Clin Exp Res. 2011 Oct-Dec;23(5-6):413-20. doi: 10.1007/BF03337766. Epub 2011 Feb 10.

    PMID: 21311211BACKGROUND

  • Gronstedt H, Frandin K, Bergland A, Helbostad JL, Granbo R, Puggaard L, Andresen M, Hellstrom K. Effects of individually tailored physical and daily activities in nursing home residents on activities of daily living, physical performance and physical activity level: a randomized controlled trial. Gerontology. 2013;59(3):220-9. doi: 10.1159/000345416. Epub 2012 Dec 20.

    PMID: 23258191RESULT

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jorunn L Helbostad, PhD

    St. Olavs University Hospital and Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

NO(1)