Effects of an Exercise Program for Nursing Home Patients With Dementia

Dementia Clinical Trial

— EXDEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262104
• Other study ID #: REK 2012-1150
• Status: Completed
• Phase: N/A
• First received: November 23, 2013
• Last updated: December 2, 2014
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo and Akershus University College of Applied Sciences	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences	Norwegian Centre for Ageing and Health, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale		12 weeks	No