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

NCT ID: NCT05686486

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2023-02-06

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.

Detailed Description

An information letter was sent to nursing homes in the Lille region (France) to present the objectives of the study. The nursing homes that agreed to participate received additional information for implementing the study. Randomisation was carried out in clusters, i.e. the sites were randomised to one of the three experimental conditions. The randomisation was carried out using Excel (Microsoft Corporation, version 18.2110.13110.0). For each site, a random value was generated and then a rank was assigned for each value. The rank value was divided by three, corresponding to the number of experimental conditions. These values were then rounded up. Each site therefore has a value of "1", "2" or "3" corresponding to an experimental condition: "1" = arm #1; "2" = arm #2; and "3" = arm #3.

The investigators of the 9 participating nursing homes screened the residents and family caregivers according to inclusion, non-inclusion and exclusion criteria. The study was then presented to residents and family caregivers who met the criteria by giving them an information letter so that they could take time to consider whether to participate in the study, with a minimum two-week cooling-off period between the information and the written consent.

The socio-demographic data collected will concern for all participants: age; gender; level of education; relationship in the dyad; previous practice of Tai Chi; usual sports and leisure activities. For residents, the Mini Mental State Examination (MMSE) score will also be collected from the medical record of each included resident and must be less than six months old. If the MMSE score is older than six months, the nursing homes will be asked to carry out the MMSE.

Two assessments of the residents and family caregivers will be carried out before the intervention and two weeks after the intervention. The assessments will be carried out by psychologists who have been previously informed and/or trained in the use of the questionnaires and scales. The information and/or training will be done by telephone. Evaluations will be conducted blind, i.e. psychologists will not be aware of the experimental condition that will be assigned to each participant. Each evaluation will last between 30 minutes and 1 hour.

Data collection in the observation books will be carried out via a code assigned to each participant in a non-identifying manner. A table of correspondence between the participants' first and last names and the codes will be kept securely by the principal investigator at each site. Once the data collection is finalised, these tables will be deleted and the codes will not appear on the computer files used for data processing and statistical analysis.

Data will be stored in each nursing home for the duration of the study. Only authorised principal investigators will have access to the consent forms and observation books for the duration of the study, which will be anonymised. The external evaluators will have access to the observation books via by the principal investigators of each sites only during the evaluations.

The coordinating investigator will make monitoring visits to ensure the proper implementation of the study and the accuracy of the consent and data collection. The coordinating investigator will also be in regular contact by email and telephone with the principal investigator at each site.

The results of the tests and scales will be processed descriptively and analysed statistically with comparisons of means between the three experimental conditions. The results will also be analysed taking into account signs of anxiety, depression and the quality of the caregiver-caregiver relationship before the start of the study. The qualitative data will be analysed for content.

Conditions

Dementia; Relation, Family

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Tai Chi inspired gymnastics

Intervention Type: OTHER

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 practised individually (residents)

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.

Group Type: ACTIVE_COMPARATOR

Tai Chi inspired gymnastics

Intervention Type: OTHER

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.

Control group (residents)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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.

Group Type: EXPERIMENTAL

Tai Chi inspired gymnastics

Intervention Type: OTHER

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 practised individually (family caregivers)

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.

Group Type: ACTIVE_COMPARATOR

Tai Chi inspired gymnastics

Intervention Type: OTHER

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.

Control group (family caregivers)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tai Chi inspired gymnastics

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malakoff-Humanis

UNKNOWN

Sponsor Role: collaborator

Siel Bleu

OTHER

Sponsor Role: collaborator

Fondation Mederic Alzheimer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Bernard Mabire, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondation Mederic Alzheimer

Locations

Résidence Les Terrasses de la Scarpe

Courchelettes, , France

EHPAD Afeji Edilys

Lille, , France

EHPAD Korian Samara

Marpent, , France

EHPAD Afeji Les Tilleuls

Maubeuge, , France

Countries

France

Other Identifiers

ID RCB : 2021-A02651-40

Identifier Type: OTHER

Identifier Source: secondary_id

FMAR-010

Identifier Type: -

Identifier Source: org_study_id