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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03216031
Other study ID # LSC/2016/55
Secondary ID 220793
Status Completed
Phase N/A
First received April 26, 2017
Last updated October 25, 2017
Start date April 24, 2017
Est. completion date September 1, 2017

Study information

Verified date October 2017
Source University of Roehampton
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Gardening programme
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.

Locations

Country Name City State
United Kingdom University of Roehampton in collaboration with St George's University Hospitals NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
University of Roehampton St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary Health Health (EQ-5D-5L Questionnaire) Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
Primary Wellbeing Wellbeing (Warwick-Edinburgh Mental Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
Primary Falls efficacy Falls efficacy scale Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
Secondary Falls and incidents 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)
Secondary Activity levels Activity Levels (assessed by means of interview question) Change from week 1 (beginning of programme) to week 8 (end of programme)
Secondary Self-efficacy General self-efficacy scale Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
Secondary Social connectedness Social connectedness scale Change in score achieved from week 1 (beginning of programme) to week 8 (end of programme)
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