Sedentary BehaviorNCT04659694
Effect of an Intervention on Health in Older Care Home Residents
A study testing Wellness programme provided by Oomph! Wellness company in people with Sedentary Behavior and Frail Elderly Syndrome, run by Bournemouth University.
Trial summary
Care home residents spent 79% of their time being sedentary. Reduced physical activity and lack of mental stimulation causes general weakness and frailty in older adults that can result in increased healthcare needs. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Frail Elderly Syndrome, Frailty
- What is being tested?
- Wellness programme provided by Oomph! Wellness company
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents' Age: 65 years of age and older living in a care home, and
- Have no cognitive impairment or in case of cognitive impairment have a score of more than 14 on the Montreal Cognitive Assessment (MOCA) screening (Nasreddine et al 2005) and who are able to provide consent or have next-of-kin/relatives/ friends who can give consent on their behalf.
- All full time care home employees and part-time employees who work in the care home on a long-term basis and interact with the care home residents
Who cannot join
- 65 years of age and above residents who score less than 14 on the MOCA screening will have moderate to severe cognitive impairment as they may not be able to follow the intervention and tests, or
- with physical or neurological condition that impedes the usage of the hand grip dynamometer, or
- with skin contraindications to wearing an accelerometer, or
- Known to have a diagnosis of severe dementia or other health conditions that contraindicate their participation in the study, or
- residents with cognitive impairment where English is not primary language as screening test is language sensitive, or
- residents who are registered blind with or without mild cognitive impairment
- Part time employees who work on an ad hoc basis and only have intermittent/minimal interaction with care home residents
About this study
Official title: The Physical and Psychosocial Effects of a Whole Systems Wellness Intervention for Older Adults Living in Care Homes: A Feasibility Study
Care home residents spent 79% of their time being sedentary. Reduced physical activity and lack of mental stimulation causes general weakness and frailty in older adults that can result in increased healthcare needs. It is important that care home residents spend their time being both physically and psychosocially engaged.
This study aims to investigate the effect of a wellness programme on physical and psychosocial wellbeing in older adults living in care homes. Through this process this study will assess the feasibility of implementing the programme and collecting data in care home settings.
Read more
There are two main groups of participants, 1) care home residents and 2) care home staff.
Care home residents will have data collected at three time points. The first time point will be before the intervention (baseline) in the care home setting. The second time point will be three months after the intervention has been delivered. The third time point will be 6 months after the intervention has been delivered.
The following measurements will be conducted:
- Measuring hand grip strength by having to grip a device as firmly as possible and measurements will be taken,
- Answering questionnaires about quality of life, daily routine, appetite, thoughts about wellness activities the participants have participated in,
- Wearing a little 'match box-like' device (that measures daily movements and sleep patterns) for 7 consecutive days.
Care home staff will be invited to participate in a focus group discussion 6 months after the intervention. Hence, this research will aim to understand the impact of a wellness programme that incorporates physical and psychosocial components that targets the holistic wellbeing of older adults.
Read the detailed description
The following potential issues have been identified:
- This feasibility study is being carried out in older adults living in care homes. Older adults are considered to be vulnerable population by the definition of the World Health Organisation.
- This study involves residents with cognitive impairment who may not be able to give consent for themselves to take part in the study. To overcome these issues, the research team is very mindful not to exclude residents with cognitive impairment who otherwise are able to participate in the Wellness activities. Th investigators will strictly adopt the Dewing process of gaining consent for older adults with cognitive impairment which involves ongoing consent monitoring. The investigators have followed the guidelines of Mental Capacity Act 2005 and designed participant information sheets and consulted declaration form who could consent on the participant's behalf (consultee). If consent is not obtained, the participant will not be recruited into the study. The consultee will be able to withdraw consent at any time in the study. Any visible distress observed during participation (eg. use of handgrip dynamometer \& accelerometer) will be recorded and the participant will be withdrawn from the study. Participants will also be regularly reminded that they can choose to withdraw from the study at any point, without any explanation and that care received would not be affected or compromised due to this study.
- All data collected will be stored on password protected computers and/or the BU secure server and will be handled in accordance with the General Data Protection Regulation 2018 and Data Protection Act 2018. Data will only be accessed by the investigator and the supervisor, and the participant's identity will be anonymised using a coding system. Conflict of Interest:
- There will be no conflict of interest in the study.
- Conditions
- Sedentary Behavior, Frail Elderly Syndrome, Frailty, Lifestyle, Sedentary, Life Style Induced Illness
- Being tested
- Wellness programme provided by Oomph! Wellness company
- Keywords
- elderly, older adults, physical activity, psychosocial activity, care home, care home staff, care home residents
- Medical subject headings
- Sedentary Behavior, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness programme provided by Oomph! Wellness companyOther
Also called Oomph! Wellness
The Oomph! wellness programme empowers older adults to lead a full life for life. It focuses on building an individual-centred programme that consists of a varied exercise and activity plans including days out. All of these, aims in improving the physical and psychosocial wellness in older adults. This intervention is a three day training session for care home staff to understand and learn how to facilitate care activities within their care home.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | This study only contains one arm Receives: Other: Wellness programme provided by Oomph! Wellness company |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer(Actigraph)
To measure the level of physical activity
Measured: Pre-intervention for 7 days
Accelerometer(Actigraph)
To measure the level of physical activity
Measured: 3 months post-intervention
Accelerometer(Actigraph)
To measure the level of physical activity
Measured: 6 months post-intervention
Barthel Index
To measure the independence in performing activities of daily living
Measured: Pre-intervention
Barthel Index
To measure the independence in performing activities of daily living
Measured: 3 months post-intervention
Barthel Index
To measure the independence in performing activities of daily living
Measured: 6 months post-intervention
Hand grip dynamometer
To measure their grip strength by using their hands to grip the dynamometer
Measured: Pre-intervention
Hand grip dynamometer
To measure their grip strength by using their hands to grip the dynamometer
Measured: 3 months post-intervention
Hand grip dynamometer
To measure their grip strength by using their hands to grip the dynamometer
Measured: 6 months post-intervention
Simplified Nutritional Appetite Questionnaire (SNAQ)
Self-administered questionnaire that will measure appetite levels
Measured: Completed pre-intervention
Simplified Nutritional Appetite Questionnaire (SNAQ)
Self-administered questionnaire that will measure appetite levels
Measured: Completed 3 months post-intervention and 6 months post intervention
Simplified Nutritional Appetite Questionnaire (SNAQ)
Self-administered questionnaire that will measure appetite levels
Measured: Completed 6 months post-intervention
EQ-5D-5L questionnaire
self-administered questionnaire that will measure quality of life
Measured: Completed pre-intervention
EQ-5D-5L questionnaire
self-administered questionnaire that will measure quality of life
Measured: Completed 3 months post-intervention and 6 months post intervention
EQ-5D-5L questionnaire
self-administered questionnaire that will measure quality of life
Measured: Completed 6 months post-intervention
Focus group discussion for care home staff
this will be a guided discussion facilitated by the researcher to understand the feasibility of implementing personalised interactive exercises \& activities in a care home
Measured: Conducted at the 6 month timeline of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study startJul 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: Withdrawal of PhD
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A mixed method design is an integrative methodology in understanding the social inquiry into the implementation of an intervention(Greene,2008). The whole system wellness intervention will be applied to care home residents by (intervention-trained) care home staff.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Oomph! Wellness, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Solent University
- Responsible party
- Sponsor
- Investigators
- Jane Murphy, Study director, Professor of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659694
- Sponsor's protocol ID
- 276089
- Status last verified
- Dec 2020
- First submitted
- 21 May 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are strictly confidential and will not be accessed by researcher. This will be assessed by care home staff.
Publications
Bradshaw SA, Playford ED, Riazi A. Living well in care homes: a systematic review of qualitative studies. Age Ageing. 2012 Jul;41(4):429-40. doi: 10.1093/ageing/afs069. Epub 2012 Jun 7.
PubMed 22678747
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physical and Psychosocial Effects of a Whole Systems Wellness Intervention for Older Adults Living in Care Homes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04659694
- Acronym / sponsor ID
- 276089
- Conditions
- Sedentary Behavior, Frail Elderly Syndrome, Frailty, Lifestyle, Sedentary, Life Style Induced Illness
- Keywords
- elderly, older adults, physical activity, psychosocial activity, care home, care home staff, care home residents
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of PhD
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Oomph! Wellness, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Solent University
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Care home residents spent 79% of their time being sedentary. Reduced physical activity and lack of mental stimulation causes general weakness and frailty in older adults that can result in increased healthcare needs. It is important that care home residents spend their time being both physically and psychosocially engaged.
This study aims to investigate the effect of a wellness programme on physical and psychosocial wellbeing in older adults living in care homes. Through this process this study will assess the feasibility of implementing the programme and collecting data in care home settings.
There are two main groups of participants, 1) care home residents and 2) care home staff.
Care home residents will have data collected at three time points. The first time point will be before the intervention (baseline) in the care home setting. The second time point will be three months after the intervention has been delivered. The third time point will be 6 months after the intervention has been delivered.
The following measurements will be conducted:
- Measuring hand grip strength by having to grip a device as firmly as possible and measurements will be taken,
- Answering questionnaires about quality of life, daily routine, appetite, thoughts about wellness activities the participants have participated in,
- Wearing a little 'match box-like' device (that measures daily movements and sleep patterns) for 7 consecutive days.
Care home staff will be invited to participate in a focus group discussion 6 months after the intervention. Hence, this research will aim to understand the impact of a wellness programme that incorporates physical and psychosocial components that targets the holistic wellbeing of older adults.
Detailed description
The following potential issues have been identified:
- This feasibility study is being carried out in older adults living in care homes. Older adults are considered to be vulnerable population by the definition of the World Health Organisation.
- This study involves residents with cognitive impairment who may not be able to give consent for themselves to take part in the study. To overcome these issues, the research team is very mindful not to exclude residents with cognitive impairment who otherwise are able to participate in the Wellness activities. Th investigators will strictly adopt the Dewing process of gaining consent for older adults with cognitive impairment which involves ongoing consent monitoring. The investigators have followed the guidelines of Mental Capacity Act 2005 and designed participant information sheets and consulted declaration form who could consent on the participant's behalf (consultee). If consent is not obtained, the participant will not be recruited into the study. The consultee will be able to withdraw consent at any time in the study. Any visible distress observed during participation (eg. use of handgrip dynamometer \& accelerometer) will be recorded and the participant will be withdrawn from the study. Participants will also be regularly reminded that they can choose to withdraw from the study at any point, without any explanation and that care received would not be affected or compromised due to this study.
- All data collected will be stored on password protected computers and/or the BU secure server and will be handled in accordance with the General Data Protection Regulation 2018 and Data Protection Act 2018. Data will only be accessed by the investigator and the supervisor, and the participant's identity will be anonymised using a coding system. Conflict of Interest:
- There will be no conflict of interest in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A mixed method design is an integrative methodology in understanding the social inquiry into the implementation of an intervention(Greene,2008). The whole system wellness intervention will be applied to care home residents by (intervention-trained) care home staff.
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Other: Wellness programme provided by Oomph! Wellness companyThis study only contains one arm |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Residents' Age: 65 years of age and older living in a care home, and
- Have no cognitive impairment or in case of cognitive impairment have a score of more than 14 on the Montreal Cognitive Assessment (MOCA) screening (Nasreddine et al 2005) and who are able to provide consent or have next-of-kin/relatives/ friends who can give consent on their behalf.
- All full time care home employees and part-time employees who work in the care home on a long-term basis and interact with the care home residents
Key exclusion criteria (7 listed)
- 65 years of age and above residents who score less than 14 on the MOCA screening will have moderate to severe cognitive impairment as they may not be able to follow the intervention and tests, or
- with physical or neurological condition that impedes the usage of the hand grip dynamometer, or
- with skin contraindications to wearing an accelerometer, or
- Known to have a diagnosis of severe dementia or other health conditions that contraindicate their participation in the study, or
- residents with cognitive impairment where English is not primary language as screening test is language sensitive, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness programme provided by Oomph! Wellness companyAlso: Oomph! WellnessThe Oomph! wellness programme empowers older adults to lead a full life for life. It focuses on building an individual-centred programme that consists of a varied exercise and activity plans including days out. All of these, aims in improving the physical and psychosocial wellness in older adults. This intervention is a three day training session for care home staff to understand and learn how to facilitate care activities within their care home. | Other | Single arm study |
Primary outcome
Accelerometer(Actigraph)
Time frame: Pre-intervention for 7 days
To measure the level of physical activity
Accelerometer(Actigraph)
Time frame: 3 months post-intervention
To measure the level of physical activity
Accelerometer(Actigraph)
Time frame: 6 months post-intervention
To measure the level of physical activity
Barthel Index
Time frame: Pre-intervention
To measure the independence in performing activities of daily living
Barthel Index
Time frame: 3 months post-intervention
To measure the independence in performing activities of daily living
Barthel Index
Time frame: 6 months post-intervention
To measure the independence in performing activities of daily living
Hand grip dynamometer
Time frame: Pre-intervention
To measure their grip strength by using their hands to grip the dynamometer
Hand grip dynamometer
Time frame: 3 months post-intervention
To measure their grip strength by using their hands to grip the dynamometer
Hand grip dynamometer
Time frame: 6 months post-intervention
To measure their grip strength by using their hands to grip the dynamometer
Simplified Nutritional Appetite Questionnaire (SNAQ)
Time frame: Completed pre-intervention
Self-administered questionnaire that will measure appetite levels
Simplified Nutritional Appetite Questionnaire (SNAQ)
Time frame: Completed 3 months post-intervention and 6 months post intervention
Self-administered questionnaire that will measure appetite levels
Simplified Nutritional Appetite Questionnaire (SNAQ)
Time frame: Completed 6 months post-intervention
Self-administered questionnaire that will measure appetite levels
EQ-5D-5L questionnaire
Time frame: Completed pre-intervention
self-administered questionnaire that will measure quality of life
EQ-5D-5L questionnaire
Time frame: Completed 3 months post-intervention and 6 months post intervention
self-administered questionnaire that will measure quality of life
EQ-5D-5L questionnaire
Time frame: Completed 6 months post-intervention
self-administered questionnaire that will measure quality of life
Focus group discussion for care home staff
Time frame: Conducted at the 6 month timeline of data collection
this will be a guided discussion facilitated by the researcher to understand the feasibility of implementing personalised interactive exercises \& activities in a care home
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Background: PubMed 22678747Bradshaw SA, Playford ED, Riazi A. Living well in care homes: a systematic review of qualitative studies. Age Ageing. 2012 Jul;41(4):429-40. doi: 10.1093/ageing/afs069. Epub 2012 Jun 7.
- Individual participant dataSharing planned: No. Individual participant data are strictly confidential and will not be accessed by researcher. This will be assessed by care home staff.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Murphy study director
Professor of Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing Wellness programme provided by Oomph! Wellness company in people with Sedentary Behavior and Frail Elderly Syndrome, run by Bournemouth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer(Actigraph) (time frame: Pre-intervention for 7 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.