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Effects of an Exercise Program for Nursing Home Patients With Dementia (EXDEM)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intensive exercise
Control
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Exercise, dementia, nursing home

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • Medically unstable
  • Longterm psychotic
  • Severe communication problems

Sites / Locations

  • Oslo and Akershus University College of Applied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intensive exercise

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Berg Balance Scale

Secondary Outcome Measures

Full Information

First Posted
November 23, 2013
Last Updated
December 2, 2014
Sponsor
Oslo Metropolitan University
Collaborators
Norwegian Centre for Ageing and Health, University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT02262104
Brief Title
Effects of an Exercise Program for Nursing Home Patients With Dementia
Acronym
EXDEM
Official Title
Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University
Collaborators
Norwegian Centre for Ageing and Health, University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia.
Detailed Description
The intervention group will be exercising one hour twice a week for 12 weeks. The participants will be doing intensive strength exercises and challenging balance exercises in groups of 4-6. Two physical therapists will be leading the intervention group. The control group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational therapist. The participants will be doing relaxation exercises, listen to music and social activities such as board games or indoor bowling. The investigators will carry out three test periods: Baseline testing before intervention start Post test after 12 weeks of intervention Follow-up 12 weeks after post test. The testing will comprise: Physical tests carried out by physiotherapists Questionnaires concerning mental health and ADL (activities of daily living) Cognition tests Cortisol in saliva

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Exercise, dementia, nursing home

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive exercise
Arm Type
Experimental
Arm Description
Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff
Intervention Type
Behavioral
Intervention Name(s)
Intensive exercise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff
Primary Outcome Measure Information:
Title
Berg Balance Scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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 Exclusion Criteria: Medically unstable Longterm psychotic Severe communication problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Bergland
Organizational Affiliation
Oslo and Akershus University college of Applied science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo and Akershus University College of Applied Sciences
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28729326
Citation
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.
Results Reference
derived
PubMed Identifier
26630910
Citation
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.
Results Reference
derived
PubMed Identifier
25974049
Citation
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.
Results Reference
derived

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Effects of an Exercise Program for Nursing Home Patients With Dementia

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