NCT05686486

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

August 26, 2024

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

January 3, 2023

Last Update Submit

August 22, 2024

Conditions

DementiaRelation, Family

Keywords

DementiaNursing homesPsychosocial interventionFamily relationshipFamily caregivers

Outcome Measures

Primary Outcomes (4)

  • Questionnaire of relationship between family caregivers and residents - Residents' point of view

    A 12-questions questionnaire will assess the family caregiver-resident relationship from the perspective of the residents. For each question, the residents will choose from four answers the one that is closest to what they think at the time of the questionnaire, e.g. "You think about your relative: all the time, often, rarely, never". Each question is rated from 0 to 3 for a maximum score of 36. A high score indicates a good perceived relationship. The questions are the same for family caregivers and residents to calculate a final relationship score by averaging the family caregiver's score and the resident's score. Additional questions not included in the score of relationship are asked to assess the relationship qualitatively.

    Baseline

  • Questionnaire of relationship between family caregivers and residents - Residents' point of view questionnaire

    A 12-questions questionnaire will assess the family caregiver-resident relationship from the perspective of the residents. For each question, the residents will choose from four answers the one that is closest to what they think at the time of the questionnaire, e.g. "You think about your relative: all the time, often, rarely, never". Each question is rated from 0 to 3 for a maximum score of 36. A high score indicates a good perceived relationship. The questions are the same for family caregivers and residents to calculate a final relationship score by averaging the family caregiver's score and the resident's score. Additional questions not included in the score of relationship are asked to assess the relationship qualitatively.

    2 weeks after the intervention

  • Questionnaire of relationship between family caregivers and residents - Family caregivers' point of view

    A 12-questions questionnaire will assess the family caregiver-resident relationship from the perspective of the family caregivers. For each question, the family caregivers will choose from four answers the one that is closest to what they think at the time of the questionnaire, e.g. "You think about your relative: all the time, often, rarely, never". Each question is rated from 0 to 3 for a maximum score of 36. A high score indicates a good perceived relationship. The questions are the same for family caregivers and residents to calculate a final relationship score by averaging the family caregiver's score and the resident's score. Additional questions not included in the score of relationship are asked to assess the relationship qualitatively.

    Baseline

  • Questionnaire of relationship between family caregivers and residents - Family caregivers' point of view

    A 12-questions questionnaire will assess the family caregiver-resident relationship from the perspective of the family caregivers. For each question, the family caregivers will choose from four answers the one that is closest to what they think at the time of the questionnaire, e.g. "You think about your relative: all the time, often, rarely, never". Each question is rated from 0 to 3 for a maximum score of 36. A high score indicates a good perceived relationship. The questions are the same for family caregivers and residents to calculate a final relationship score by averaging the family caregiver's score and the resident's score. Additional questions not included in the score of relationship are asked to assess the relationship qualitatively.

    2 weeks after the intervention

Secondary Outcomes (4)

  • Hospital Anxiety and Depression Scale (HAD)

    Baseline and 2 weeks after the intervention

  • Sense of Competence Questionnaire (QSC)

    Baseline and 2 weeks after the intervention

  • Quality of Life-Alzheimer's Disease scale in Nursing Homes (QOL-AD NH)

    Baseline and 2 weeks after the intervention

  • Mini Mental State Examination (MMSE)

    Baseline

Study Arms (6)

Tai Chi inspired gymnastics practiced in a family caregiver-resident dyad (residents)

EXPERIMENTAL

15 participants in 3 groups with 5 residents per group who benefited with 5 family caregivers from the Tai Chi inspired gymnastics programme at a rate of two one-hour sessions per week for 12 weeks.

Other: Tai Chi inspired gymnastics

Tai Chi inspired gymnastics practised individually (residents)

ACTIVE COMPARATOR

30 participants in 3 groups with 10 residents per groups who benefited separately from the family caregivers from the Tai Chi inspired gymnastics programme at a rate of two one-hour sessions per week for 12 weeks.

Other: Tai Chi inspired gymnastics

Control group (residents)

NO INTERVENTION

15 participants in 3 groups with 5 residents. As well as their family carers, they did not benefit from the intervention the study. They will be able to continue their usual activities. At the end of the study, they will be offered the 24 sessions of the Tai Chi inspired gymnastics programme in family caregiver-resident dyad.

Tai Chi inspired gymnastics practiced in a family caregiver-resident dyad (family caregivers)

EXPERIMENTAL

15 participants in 3 groups with 5 family caregivers per group who benefited with 5 residents from the Tai Chi inspired gymnastics programme at a rate of two one-hour sessions per week for 12 weeks.

Other: Tai Chi inspired gymnastics

Tai Chi inspired gymnastics practised individually (family caregivers)

ACTIVE COMPARATOR

30 participants in 3 groups with 10 family caregivers per groups who benefited separately from the residents from the Tai Chi inspired gymnastics programme at a rate of two one-hour sessions per week for 12 weeks.

Other: Tai Chi inspired gymnastics

Control group (family caregivers)

NO INTERVENTION

15 participants in 3 groups with 5 family caregivers. As well as the residents, they did not benefit from the intervention the study. They will be able to continue their usual activities. At the end of the study, they will be offered the 24 sessions of the Tai Chi inspired gymnastics programme in family caregiver-resident dyad.

Interventions

Tai Chi inspired gymnasticsOTHER

The intervention programme will address the themes of "relax and seek flexibility" and "contact and follow". The programme will be divided into four parts with six sessions per part. A typical session will be as follows: * Joint warm-up * A body session focused on relaxation and flexibility in different planes: sagittal/sagittal and frontal/sagittal, frontal and transversal/sagittal, frontal and transversal. * A more playful session in pairs on the theme of "contact and follow". Example: put the back of your hand against the back of your partner's hand and initiate movements and the other must follow without resistance.

Tai Chi inspired gymnastics practiced in a family caregiver-resident dyad (family caregivers)Tai Chi inspired gymnastics practiced in a family caregiver-resident dyad (residents)Tai Chi inspired gymnastics practised individually (family caregivers)Tai Chi inspired gymnastics practised individually (residents)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

RĂ©sidence Les Terrasses de la Scarpe

Courchelettes, 59552, France

Location

EHPAD Afeji Edilys

Lille, 59000, France

Location

EHPAD Korian Samara

Marpent, 59164, France

Location

EHPAD Afeji Les Tilleuls

Maubeuge, 59600, France

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jean-Bernard Mabire, PhD

    Fondation Mederic Alzheimer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Investigators, participants and professionals are aware of the experimental condition. Only the external evaluators do not know which experimental condition the participants are in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The experimental design is a cluster randomised controlled study with three arms corresponding to three experimental conditions. Sixty dyads will be recruited for a total of 120 participants (60 family caregivers and 60 residents) divided into 12 groups. 9 nursing homes are participating.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 17, 2023

Study Start

September 9, 2022

Primary Completion

February 6, 2023

Study Completion

February 6, 2023

Last Updated

August 26, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)