Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8 Nature for All

Mobility Disability Clinical Trial

— RESONATE-CS8  

Official title:

Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205940
• Other study ID #: 101081420
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of Copenhagen
• Contact: Ulrika K Stigsdotter, PHD
• Phone: 40110801
• Email: uks[@]ign.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled trial is to test if digital engagement instructions (a nature guide APP) can enhance the nature connection and provide positive health outcomes for individuals with mobility disabilities. The study has an active control group, that will have the same nature exposure without the guidance of the APP. 124 participants will be randomized to either the intervention group or the control group. The intervention consists of two parts: Intervention day 1: The intervention starts for both the 'intervention group' and the 'control group' in the Hoersholm arboretum, which contain Denmark's largest collection of different trees and shrubs. The intervention group will listen to the 'intervention APP' during a tour with three stops along a trail in the arboretum. The active control group will take the same tour but does not have access to the 'intervention APP'. 4 week intervention: During the following 4 weeks the participants will be encouraged to visit nature for 120 minutes in total per week on their own. The intervention group will still be encouraged to use the APP during the nature visits.

Description:

See protocol

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Not being able to walk at all or be able to walk short distances (ICF 2017: d4500, walking short distances; walking for less than a kilometer, such as walking around rooms or hallways, within a building or for short distances outside)
• All types of assistive devices, including e.g. scooters, walkers, and canes. Also service dogs and personal carers are included.
• Adults (+18 years)
• All genders
• All educational levels
• All religious affiliations
• All types of marital status
• All types of households
• All types of employment and income

Exclusion Criteria:

• - Do not understand Danish (APP, questionnaires and interviews in Danish)
• Physically not able to use a smartphone with touch screen, by themselves or with the help of a personal carer
• Participating in mindfulness program during intervention (intervention day 1 and 4-week intervention period)
• Cognitive limitations (difficulties in understanding and using information from APP, understanding and responding to questionnaires and interviews.)
• Known drug or alcohol abuse
• Diagnosed epilepsy

Related Conditions & MeSH terms

• Mobility Disability

Intervention

Behavioral:
• Audioguided Nature tour
Listening to audio instructions by an app while visiting nature. The instructions emphasize the connection between self and nature and direct attention to the present moment experience by guiding focus towards sensory experiences and specific natural elements.
• Non audio guided nature tour
Visiting nature without listening to audio instructions by an app

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eye-tracking	Portable eye-tracking recording	During tour on intervention day 1
Other	System Usability Scale	The System Usability Scale (SUS) consists of 10 question, scored on a 5 point likert scale ranging from strongly disagree (0) to strongly agree (4), where item 2,4,6,8 and 10 have reverse scoring. A higher score indicate higher level of perceived usability.	After tour on intervention day 1
Primary	The Nature Connection Index	Questionnaire Nature Connection Index (NCI) is a 6-item self-report measure of connection to nature. The level of agreement with each of the 6 statements is rated on a scale from 1 (completely agree) to 7 (completely disagree), where a higher score indicates higher level of nature connection.	Baseline 0 (1 week before intervention), After intervention day 1, End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
Secondary	the State Mindfulness Scale	The State Mindfulness Scale (SMS) is a 21-item self-report measure of state mindfulness. The level of agreement with each of the 21 statements is rated on a scale from 1 (not at all) to 5 (very much), where a higher score indicates higher level of state mindfulness.	Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)
Secondary	The Restorative Outcome Scale	The Restorative Outcome Scale (ROS) is a 6-item self-report measure of the restorative effect of natural environments. The level of agreement with each of the six statement is rated on a 7 point scale from 0 (completely disagree) to 6 (completely agree), where a higher score indicates higher level of self perceived restorative outcome.	After tour on intervention day 1, End of intervention (after 4 months)
Secondary	The Subjective Vitality Scale	The Subjective Vitality Scale (SVS) is a 6-item self-report measure of subjective vitality. The level of agreement with each of the six statement is rated on a 7 point scale from 1(completely disagree) to 7 (completely agree), where a higher score indicates higher level of subjective vitality.	Baseline 0 (1 week before intervention), After intervention day 1, End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
Secondary	The State-Trait Assessment of Resilience Scale	The State-Trait Assessment of Resilience Scale (STARS) is a 7-item self-report measure of resilience. The level of agreement with each of the 7 statements is rated on a 4 point scale from 1(disagree) to 4 (completely agree). Item 3,4,5 have reverse scoring. A higher score indicates higher level of subjective vitality.	Baseline 0 (1 week before intervention), After intervention day 1, End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
Secondary	Heart Rate Variability	HRV analysis will be performed on electrocardiograms, ECG signals	During tour on intervention day 1
Secondary	The Health-related Quality of Life Short Form Survey	The Health-related Quality of Life Short Form Survey (SF-12) is a 12-item Short Form Survey measuring health related quality of life. Each question is answered on a 6 point scale ranging from not at all (1) to all the time (6). A higher total score indicates higher level of health-related quality of life.	Baseline 0 (1 week before intervention), End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up