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Trial record 1 of 1 for:    NCT02262104
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Effects of an Exercise Program for Nursing Home Patients With Dementia (EXDEM)

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ClinicalTrials.gov Identifier: NCT02262104
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborators:
Norwegian Centre for Ageing and Health
University of Oslo
Information provided by (Responsible Party):
Elisabeth Wiken Telenius, Oslo Metropolitan University

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

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Intensive exercise Behavioral: Control Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive exercise
Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists.
Behavioral: Intensive exercise
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

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




Primary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262104


Locations
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Norway
Oslo and Akershus University College of Applied Sciences
Oslo, Norway
Sponsors and Collaborators
Oslo Metropolitan University
Norwegian Centre for Ageing and Health
University of Oslo
Investigators
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Principal Investigator: Astrid Bergland Oslo and Akershus University college of Applied science

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elisabeth Wiken Telenius, Research Fellow, Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT02262104    
Other Study ID Numbers: REK 2012-1150
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Elisabeth Wiken Telenius, Oslo Metropolitan University:
Exercise
dementia
nursing home
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders