- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216031
Project Grow: Establishing an Intergenerational Falls Prevention Gardening Programme (PGROW)
October 25, 2017 updated by: Sandra Klaperski, University of Roehampton
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- University of Roehampton in collaboration with St George's University Hospitals NHS Foundation Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical effects 1/3
Time Frame: Change in sec needed from week 1 (beginning of programme) to week 8 (end of programme)
|
Timed Up and Go time (in sec)
|
Change in sec needed from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Physical effects 2/3
Time Frame: Change in number of stands achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Number stands in 30 sec Sit-to-Stand test
|
Change in number of stands achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Physical effects 3/3
Time Frame: Change in numbers of steps needed from week 1 (beginning of programme) to week 8 (end of programme)
|
Turn test (n steps to turn 180 degrees)
|
Change in numbers of steps needed from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Health
Time Frame: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Health (EQ-5D-5L Questionnaire)
|
Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Wellbeing
Time Frame: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Wellbeing (Warwick-Edinburgh Mental
|
Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Falls efficacy
Time Frame: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Falls efficacy scale
|
Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls and incidents
Time Frame: Number of falls/incidents recorded during the programme (week 1-8)
|
Number of falls or other incidences during the gardening programme to judge its feasibility and risks.
|
Number of falls/incidents recorded during the programme (week 1-8)
|
|
Activity levels
Time Frame: Change from week 1 (beginning of programme) to week 8 (end of programme)
|
Activity Levels (assessed by means of interview question)
|
Change from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Self-efficacy
Time Frame: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
General self-efficacy scale
|
Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
|
Social connectedness
Time Frame: Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Social connectedness scale
|
Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
April 26, 2017
First Submitted That Met QC Criteria
July 10, 2017
First Posted (Actual)
July 12, 2017
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 25, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LSC/2016/55
- 220793 (Other Identifier: HRA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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