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

December 2, 2014 updated by: Elisabeth Wiken Telenius, Oslo Metropolitan University

Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo and Akershus University College of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Berg Balance Scale
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo Metropolitan University

Collaborators

University of Oslo
Norwegian Centre for Ageing and Health

Investigators

  • Principal Investigator: Astrid Bergland, Oslo and Akershus University college of applied science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 23, 2013

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 2012-1150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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