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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • London, United Kingdom
        • University of Roehampton in collaboration with St George's University Hospitals NHS Foundation Trust

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roehampton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St George's University Hospitals NHS Foundation Trust

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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