Mobility DisabilityRESONATE-CS8NCT06205940
Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8 Nature for All
A study testing Audioguided Nature tour and Non audio guided nature tour in people with Mobility Disability, run by University of Copenhagen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility Disability
- What is being tested?
- Audioguided Nature tour and Non audio guided nature tour
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- All types of marital status
- All types of households
- All types of employment and income
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8
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.
Read more
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.
Read the detailed description
See protocol
- Conditions
- Mobility Disability
- Being tested
- Audioguided Nature tour, Non audio guided nature tour
- Keywords
- nature app, nature connection, forest walks, mobility disability, resilience, eyetracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audioguided Nature tourBehavioural
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 tourBehavioural
Visiting nature without listening to audio instructions by an app
| Study group | Role | What they receive |
|---|---|---|
| Audio guided nature tour | Experimental | Listening to audio instructions by an app while visiting nature. Receives: Behavioral: Audioguided Nature tour |
| Non audio guided nature tour | Active comparator | Visiting nature without audio guided instructions (app). Receives: Behavioral: Non audio guided nature tour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (6)
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.
Measured: Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)
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.
Measured: After tour on intervention day 1, End of intervention (after 4 months)
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.
Measured: 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
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.
Measured: 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
Heart Rate Variability
HRV analysis will be performed on electrocardiograms, ECG signals
Measured: During tour on intervention day 1
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.
Measured: Baseline 0 (1 week before intervention), End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility DisabilityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrika K Stigsdotter, PHD, Principal investigator, University of Copenhagen - IGN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205940
- Sponsor's protocol ID
- 101081420
- Acronym
- RESONATE-CS8
- Status last verified
- May 2024
- First submitted
- 3 Jan 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is shared exclusively in pseudonymized form with all partners in the RESONATE project. The countries included in RESONATE are: Denmark, Spain, Italy, Belgium, Sweden, Bulgaria, Austria, and the Netherlands. The UK is an associated partner.
Publications
White MP, Egger JAM, Amato G, Astell-Burt T, Bekke-Hansen S, Borja A, Burov A, Busse S, Costongs C, Dimitrova D, Doimo I, Dzhambov AM, Elliott LR, Godfrey A, Grellier J, Hartig T, Hartl A, Nyed PK, Konijnendijk C, Lem M, Litt JS, Lovell R, Lymeus F, Mammadova A, Martin L, Moe A, Trimmer SM, O'Driscoll C, Ostberg J, Pahl S, Pazzaglia F, Pichler C, Poole A, Pouso S, Razani N, Rogelja T, Secco L, Stigsdotter UK, Corazon SS, Sowman G, Uyarra MC, van den Berg AE, van Rompay T, Voracek M, Wells NM, Wheeler BW, van den Bosch M. Testing nature-based biopsychosocial resilience theory: a research programme protocol. Arch Public Health. 2026 Apr 24;84(1):90. doi: 10.1186/s13690-026-01903-5.
PubMed 42032758
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Individual and Community Resilience Through Nature-based Therapies - Case Study 8
- ClinicalTrials.gov ID
- NCT06205940
- Acronym / sponsor ID
- RESONATE-CS8 / 101081420
- Conditions
- Mobility Disability
- Keywords
- nature app, nature connection, forest walks, mobility disability, resilience, eyetracking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See protocol
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Audio guided nature tour | Experimental | Behavioral: Audioguided Nature tourListening to audio instructions by an app while visiting nature. |
| Non audio guided nature tour | Active comparator | Behavioral: Non audio guided nature tourVisiting nature without audio guided instructions (app). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audioguided Nature tourListening 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. | Behavioural | Audio guided nature tour |
| Non audio guided nature tourVisiting nature without listening to audio instructions by an app | Behavioural | Non audio guided nature tour |
Primary outcome
The Nature Connection Index
Time frame: 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
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.
6 secondary outcomes
the State Mindfulness Scale
Time frame: Baseline 1 (just before intervention), After tour on intervention day 1, End of intervention (after 4 months)
The Restorative Outcome Scale
Time frame: After tour on intervention day 1, End of intervention (after 4 months)
The Subjective Vitality Scale
Time frame: 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
The State-Trait Assessment of Resilience Scale
Time frame: 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
Heart Rate Variability
Time frame: During tour on intervention day 1
The Health-related Quality of Life Short Form Survey
Time frame: Baseline 0 (1 week before intervention), End of intervention (after 4 months), 1 month follow-up, 3 month-follow up, 6-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 42032758White MP, Egger JAM, Amato G, Astell-Burt T, Bekke-Hansen S, Borja A, Burov A, Busse S, Costongs C, Dimitrova D, Doimo I, Dzhambov AM, Elliott LR, Godfrey A, Grellier J, Hartig T, Hartl A, Nyed PK, Konijnendijk C, Lem M, Litt JS, Lovell R, Lymeus F, Mammadova A, Martin L, Moe A, Trimmer SM, O'Driscoll C, Ostberg J, Pahl S, Pazzaglia F, Pichler C, Poole A, Pouso S, Razani N, Rogelja T, Secco L, Stigsdotter UK, Corazon SS, Sowman G, Uyarra MC, van den Berg AE, van Rompay T, Voracek M, Wells NM, Wheeler BW, van den Bosch M. Testing nature-based biopsychosocial resilience theory: a research programme protocol. Arch Public Health. 2026 Apr 24;84(1):90. doi: 10.1186/s13690-026-01903-5.
- Individual participant dataSharing planned: Yes. Data is shared exclusively in pseudonymized form with all partners in the RESONATE project. The countries included in RESONATE are: Denmark, Spain, Italy, Belgium, Sweden, Bulgaria, Austria, and the Netherlands. The UK is an associated partner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrika K Stigsdotter, PHD principal investigator
University of Copenhagen - IGN
Questions about this trial
What is this clinical trial studying?
A study testing Audioguided Nature tour and Non audio guided nature tour in people with Mobility Disability, run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrika K Stigsdotter, PHD (40110801 ext. +45, uks@ign.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nature Connection Index (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06205940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.