Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT05686486

Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes

Conditions: Dementia, Relation, Family

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 120
Sponsor: Fondation Mederic Alzheimer

Location: France

Summary

The goal of this multicentre cluster randomised controlled trial is to evaluate the effects of a joint practice of a Tai Chi inspired gymnastics programme in nursing home on the relationship between family caregivers and residents living with mild to moderate dementia. The intervention consists of 24 sessions of Tai Chi inspired gymnastics programme for two one-hour sessions per week in a family caregiver-resident pair. The researchers will compare the practice of the intervention in pairs with a separate practice and with the absence of intervention to see if any effects are observed on the family caregiver-resident relationship. The hypotheses are as follows:Hypothesis 1: the relationship between family caregiver and resident will be judged better after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.Hypothesis 2: signs of anxiety and depression in the family caregiver and resident should be lower after joint practice of a Tai Chi inspired gymnastics programme compared to separate practice and compared to no intervention.Hypothesis 3: the family caregivers' feeling of competence will be higher after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.Hypothesis 4: the quality of life of the residents will be better after the joint practice of a Tai Chi inspired gymnastics programme compared to a separate practice and compared to no intervention.

Eligibility Criteria

Inclusion Criteria for the residents:Agreement of the resident and the family caregiver to participate in the study;Presence of neurocognitive disorders mentioned in the resident's file and objectified by a MMSE score between 16 and 25 out of 30;Presence in the nursing home for more than six months;Ability to attend the sessions;Ability to walk to the place of the intervention alone, with human or technical assistance.Medical advice indicating the possibility of practising the activity.Exclusion Criteria for the residents:Refusal of the resident or of the family caregiver to continue the study;Alteration of the general state of health no longer allowing participation in the sessions and assessments;Hospitalization(s) that do not allow regular follow-up of the sessions and evaluations;Permanent leaving of the nursing home;Death.Inclusion Criteria for the family caregivers:Medical certificate by the general practitioner indicating the possibility of carrying out the Tai Chi inspired gymnastics sessions;Family caregiver having frequent contact with the resident: spouse; child; brother/sister; cousin;Agreement of the family caregiver and the resident to participate in the study;Absence of neurocognitive disorders;Ability to attend the proposed sessions;Operational mobility to go to the intervention site.Exclusion Criteria for the family caregivers:Refusal of the family caregiver or of the resident to continue the study;Alteration of the general state of health no longer allowing participation in the sessions and assessments;Hospitalization(s) that do not allow regular follow-up of the sessions and evaluations;Death.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05686486). StuddyBuddy aggregates publicly available trial information.