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Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation (Rocking)

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ClinicalTrials.gov Identifier: NCT04101084
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care.

Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant.

We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation.

Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy.

The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.


Condition or disease Intervention/treatment Phase
Dementia Other: Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rocking Chair Therapy: A Non Pharmacological Intervention in Elderly With Dementia, Its Effects in Agitation, Pharmacological Restraint Use, and Pain
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : August 25, 2022
Estimated Study Completion Date : December 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Rocking chair therapy
Rocking sessions in a safe rocking chair for 2 hours daily for six weeks
Other: Therapy
Rocking sessions in a safe rocking chair for 2 hours daily for six weeks




Primary Outcome Measures :
  1. Change of agitation [ Time Frame: At 6 weeks ]
    Change from Baseline agitation at 6 weeks. The agitation will be evaluated using Cohen Mnasfiled agitation inventory a week before therapy, and the week after.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • resident of the EHPAD / LTC for at least 10 weeks
  • subject with cognitive impairment (MMSE <24) documented according to DSM-5 criteria
  • with chronic behavioral disorders such as agitation
  • stable from a medical point of view
  • without restraint when not in bed
  • ability to touch the floor with the toes while sitting in the rocking chair
  • ability to sit securely in the rocking chair
  • ability to tolerate rocking chair
  • Ability to maintain active rocking for at least 5 minutes over a 30-minute period during the three pre-treatment trials
  • obligation for all patients to be affiliated to a social security scheme
  • signing of the informed consent by the patient and / or his legal representative

Exclusion Criteria:

  • Motor deficiency (example: after-effects of stroke ...) not allowing a secure installation in the chair or preventing an active rocking
  • ATCC with vestibular involvement that may lead to vertiginous seizures during rocking
  • Aging psychiatric pathology

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): NCT04101084


Contacts
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Contact: ZAAFRANE Malek, Ph +3392034060 zaafrane.m@chu-nice.fr

Locations
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France
CHU de Nice - Gérontology Recruiting
Nice, Alpes-Maritime, France, 06100
Contact: ZAAFRANE MAlek, Ph    +3392034060    zaafrane.m@chu-nice.fr   
Principal Investigator: ZAAFRANE Malek         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: ZAAFRANE Malek, Ph Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04101084    
Other Study ID Numbers: 18-AOIP-03
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders