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FallPGROWNCT03216031

Project Grow: Establishing an Intergenerational Falls Prevention Gardening Programme

A study testing Gardening programme in people with Fall, run by University of Roehampton at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Wandsworth Integrated Falls and Bone Health Service (IF \& BHS) provides an evidence-based falls prevention exercise programme, but yearly about 500 of 1800 patients decline participation or do not continue to exercise. Read more about this study

Who is it for?
Any age
Conditions the study is for
Fall
What is being tested?
Gardening programme
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
24 Apr 2017to 1 Sep 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Having had a Falls and Bone Health Assessment by the Integrated Falls and Bone Health Service (IF \& BHS) Wandsworth
  • Having falls or bone health risk factors but being able to mobilise without walking aids
  • Having been assessed by IF \& BHS as having capacity to take part in a gardening intervention programme
  • Having indicated an interest in attending a gardening group following the IF \& BHS assessment if they a) do not want to participate in any other elements of the IF \& BHS programme or if they b) have completed other elements of the service offered by the IF \& BHS, e.g. exercise groups, Nordic walking or Zumba gold.

Who cannot join

  • Having a known diagnosis of dementia
  • Not being able to adequately understand verbal explanations or written information given in English
  • Having a falls risk profile that indicates that the individual has high falls risk in this context - this is a clinical decision and will take account of a number of variables including mobility (Timed up \& Go of more than 20 sec) and their general health (e.g., large postural drop, uncontrolled diabetes, significant behaviour that challenges).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Roehampton in collaboration with St George's University Hospitals NHS Foundation Trust

    London

Other trials in United Kingdom

About this study

Official title: Project GROW: Establishing and Testing a New Intergenerational Falls Prevention Gardening Programme to Improve Physical Activity Levels, Health and Wellbeing in Older People at Risk of Falling

Wandsworth Integrated Falls and Bone Health Service (IF \& BHS) provides an evidence-based falls prevention exercise programme, but yearly about 500 of 1800 patients decline participation or do not continue to exercise. Our study seeks to address this efficiency gap by developing a gardening programme as an alternative to traditional exercise. In a preparation period (4/17-5/17) we will explore the special needs of the target population through interviews and create an age appropriate gardening site at "Growhampton", a gardening project run by the University of Roehampton; from 5/17 to 9/17 a falls prevention gardening group will be implemented and evaluated.

Read the detailed description

The key purpose of the study is to provide and test an intergenerational gardening project as a choice for about 30 IF \& BHS patients who would otherwise decline exercise interventions. Patients previously assessed by Wandsworth Integrated Falls \& Bone Health Services have identified gardening as an enjoyable alternative to exercise classes. Gardening sessions will take place weekly (aiming for 3 groups with 10 patients and 2-4 students and/or staff members of the University of Roehampton). Through engaging patients in gardening activities the study seeks to achieve 4 main aims: 1. Increase physical activity levels; 2. improve mental and physical health outcomes; 3. foster self-efficacy and social connectedness; 4. reduce the risk of falls. The at falls risk population will benefit by engaging in a meaningful activity (designed and supported by clinicians and aided by students and staff members) which delivers on the core principles of strength, power, balance and coordination.

Conditions
Fall
Being tested
Gardening programme
Keywords
Falls prevention, Gardening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardening programmeBehavioural

    3 groups with up to 10 patients and 2-4 students/staff members each should meet once per week for about 1 hour to engage in gardening activities at the falls prevention growing site. Each participant will attend the programme 8 times.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical effects 1/3

    Timed Up and Go time (in sec)

    Measured: Change in sec needed from week 1 (beginning of programme) to week 8 (end of programme)

  2. Physical effects 2/3

    Number stands in 30 sec Sit-to-Stand test

    Measured: Change in number of stands achieved from week 1 (beginning of programme) to week 8 (end of programme)

  3. Physical effects 3/3

    Turn test (n steps to turn 180 degrees)

    Measured: Change in numbers of steps needed from week 1 (beginning of programme) to week 8 (end of programme)

  4. Health

    Health (EQ-5D-5L Questionnaire)

    Measured: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)

  5. Wellbeing

    Wellbeing (Warwick-Edinburgh Mental

    Measured: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)

  6. Falls efficacy

    Falls efficacy scale

    Measured: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)

Secondary outcomes (4)

  1. Falls and incidents

    Number of falls or other incidences during the gardening programme to judge its feasibility and risks.

    Measured: Number of falls/incidents recorded during the programme (week 1-8)

  2. Activity levels

    Activity Levels (assessed by means of interview question)

    Measured: Change from week 1 (beginning of programme) to week 8 (end of programme)

  3. Self-efficacy

    General self-efficacy scale

    Measured: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)

  4. Social connectedness

    Social connectedness scale

    Measured: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study start24 Apr 2017
  3. Primary completion1 Sep 2017
  4. Study completion1 Sep 2017

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
In the implementation phase, a falls prevention gardening group will be implemented. Staff members of the Integrated Falls and Bone Health Service will offer their patients who decline to take part in the standard prevention exercise programme or who have completed the other prevention classes to participate in a gardening programme. The goal is to recruit 30 patients as participants of the gardening programme and to engage them in weekly gardening activities for 8 weeks (either 8 weeks in a row or 8 attendances over 3 months to allow for sickness / other reasons for non-attendance). 3 groups with up to 10 patients and 2-4 students/staff members each should meet once per week for about 1 hour to engage in gardening activities at the new growing site. Only participants who have passed the risk screening of the Integrated Falls and Bone Health Service and who meet all inclusion criteria will be invited to join the gardening programme.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216031
Sponsor's protocol ID
LSC/2016/55
Other IDs
220793
Acronym
PGROW
Status last verified
Oct 2017
First submitted
26 Apr 2017
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gardening programme in people with Fall, run by University of Roehampton at 1 site in United Kingdom.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Physical effects 1/3 (time frame: Change in sec needed from week 1 (beginning of programme) to week 8 (end of programme)). The study lists 6 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 NCT03216031.

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 26 Oct 2017.

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