NCT03216031

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

April 26, 2017

Last Update Submit

October 25, 2017

Conditions

Keywords

Falls preventionGardening

Outcome Measures

Primary Outcomes (6)

  • Physical effects 1/3

    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

    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

    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

    Health (EQ-5D-5L Questionnaire)

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

  • Wellbeing

    Wellbeing (Warwick-Edinburgh Mental

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

  • Falls efficacy

    Falls efficacy scale

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

Secondary Outcomes (4)

  • Falls and incidents

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

  • Activity levels

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

  • Self-efficacy

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

  • Social connectedness

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

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Sport and Exercise Psychology

Study Record Dates

First Submitted

April 26, 2017

First Posted

July 12, 2017

Study Start

April 24, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations