NCT02262104

Brief Summary

The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

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

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

November 23, 2013

Last Update Submit

December 2, 2014

Conditions

Keywords

Exercisedementianursing home

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    12 weeks

Study Arms (2)

Intensive exercise

EXPERIMENTAL

Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists.

Behavioral: Intensive exercise

Control

PLACEBO COMPARATOR

Control group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff

Behavioral: Control

Interventions

Arm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist

Intensive exercise
ControlBEHAVIORAL

Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff

Control

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>55 years old
  • Living in nursing home
  • Able to stand with help from max 1
  • Able to walk 6 meters with or without walking aid

You may not qualify if:

  • Medically unstable
  • Longterm psychotic
  • Severe communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo and Akershus University College of Applied Sciences

Oslo, Norway

Location

Related Publications (3)

  • Kvael LAH, Bergland A, Telenius EW. Associations between physical function and depression in nursing home residents with mild and moderate dementia: a cross-sectional study. BMJ Open. 2017 Jul 20;7(7):e016875. doi: 10.1136/bmjopen-2017-016875.

  • Telenius EW, Engedal K, Bergland A. Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial. BMC Geriatr. 2015 Dec 3;15:158. doi: 10.1186/s12877-015-0151-8.

  • Telenius EW, Engedal K, Bergland A. Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial. PLoS One. 2015 May 14;10(5):e0126102. doi: 10.1371/journal.pone.0126102. eCollection 2015.

MeSH Terms

Conditions

DementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Astrid Bergland

    Oslo and Akershus University college of Applied science

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

November 23, 2013

First Posted

October 10, 2014

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations