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Chronic DiseasePARC-2NCT07002853

Nature-based Intervention for Chronic Pain in Older People

A study testing Nature-based Intervention in people with Chronic Disease and Chronic Pain (Back / Neck), run by Université du Québec à Chicoutimi at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn if a nature-based intervention program has positive effects on the physical and psychosocial health in a group of older participants with chronic non-specific lower back pain. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Nature-based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteCanada
Study dates
22 May 2025to 1 Sep 2026
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged 65 years +
  • Having low back pain for 3 months or more
  • Being able to walk independently
  • Mental state >25/30 in the MMSE questionnaire
  • Frailty score <3/5 (Fried criterias)

Who cannot join

  • Presenting other severe musculoskeletal, cardiovascular, or neurological conditions, or systemic diseases (e.g., cancer).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Université du Québec à Chicoutimi

    Saguenay, Quebec, G7H 2B1

Other trials in Canada

About this study

Official title: Nature-based Intervention Program for Sustainable Health in Older People Living With Chronic Non-specific Lower Back Pain (PARC Project 2) - A Feasibility Trial

The goal of this clinical trial is to learn if a nature-based intervention program has positive effects on the physical and psychosocial health in a group of older participants with chronic non-specific lower back pain. The main questions it aims to answer are:

Will the program improve:

  • The physical outcomes such as mobility, strength and balance?
  • The psychosocial health outcomes?

Participants will:

  • Be assessed before and after the program;
  • Participate in one session per week of the intervention.
Read the detailed description

Nonspecific chronic low back pain is defined as persistent pain located between the lower ribs and the gluteal fold, with no identifiable pathoanatomical cause. It is associated with decreased quality of life, mental well-being, increased work absenteeism, and represents a significant economic burden for both individuals and the healthcare system. In the scientific literature, physical activity remains the primary recommended intervention. Recently, nature-based interventions have also been explored as a potential multidisciplinary ally for the management of chronic pain.

The objective of this study is to examine the effects of outdoor physical activity (i.e. walking, general back mobility and strengthening) combined with other nature interventions (i.e. shinrin-yoku, meditation, gardening and pain education) in a group of older adults living with chronic non-specific lower back pain. The intervention will consist of an 8-week group program, conducted once a week for 2 hours. A total of 15 participants will take part in the program to evaluate its impact on both physical and mental health.

Data collection will include both quantitative and qualitative measures. Quantitative outcomes will assess pain disability, quality of life, kinesiophobia (fear of movement), fear of falling, pain catastrophisation, pain beliefs, well-being, depression, nature connectedness, and physical function through standardized tests (e.g., 5 Times Sit to Stand Test), postural control, and gait patterns. Statistical analyses will be performed to compare pre- and post-intervention outcomes, as well as to explore associations between clinical variables, using SPSS software.

Qualitative data will be collected through individual interviews conducted before and at the end of the program to provide a richer understanding of participants' experiences of pain and perceived effects of the program. Interview transcripts will be analyzed using NVivo software.

It is anticipated that this type of intervention will have positive effects for this population and may be considered a promising rehabilitation approach for the management of chronic low back pain in older adults.

Being tested
Nature-based Intervention
Keywords
Aging, Chronic pain, Non-specific low back pain, Nature-based interventions, Falls, Forest bathing, Shinrin-yoku, Social, Nature connectedness, Functionning, Physical activity, Mindfulness, Meditation, Rehabilitation, Postural control, Strength, Quality of life, Balance
Medical subject headings
Chronic Disease, Chronic Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nature-based InterventionOther

    Combination of activities in nature such as walking, exercises (strengthening, mobility, balance), mindfulness, guided meditation, forest bathing or Shinrin-Yoku, interpretation of nature, gardening and pain education.

Study groups in NCT07002853
Study groupRoleWhat they receive
Nature-based interventionExperimentalNature-based intervention group of once a week (2 hours) for 8 weeks
Receives: Other: Nature-based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention rate

    Proportion of participants completing the full protocol, including pre and post intervention assessments.

    Measured: 8 weeks

  2. Adherence to supervised outdoor sessions

    Proportion of scheduled supervised outdoor sessions completed by each participant. Calculated as number of sessions completed ÷ number of sessions planned.

    Measured: 8 weeks

  3. Dropout rate

    Proportion of participants who discontinue participation before completing the intervention.

    Measured: 8 weeks

  4. Participant satisfaction

    Participant Satisfaction was measured using the "Participant Satisfaction Likert Scale", a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree). Higher scores indicate greater satisfaction with the intervention, including clarity of instructions, perceived usefulness, exercise difficulty, and overall acceptability.

    Measured: through study completion, an average of 8 weeks.

  5. Adverse effects

    Number and type of adverse events reported during the intervention, documented after each session.

    Measured: 8 weeks

  6. Qualitative feedback on perceived benefits

    Qualitative feedback collected after each session through brief open ended questions documenting perceived benefits such as increased hope, enhanced social interaction, and other emergent themes.

    Measured: 8 weeks

  7. Well-being state (WHO-5)

    The World Health Organization Well-Being Index (WHO-5) is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life.The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.

    Measured: change from baseline at 0 to 8 weeks

  8. Depression state (PHQ-9)

    The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, monitor, and measure the severity of depression. It consists of nine questions based on the diagnostic criteria for major depressive disorder in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).Respondents rate how often they have experienced each symptom over the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). The scores are then added together to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms

    Measured: change from baseline at 0 to 8 weeks

  9. Connection to nature (CNS)

    The Connectedness to Nature Scale (CNS) is a psychological assessment tool designed to measure an individual's subjective connection to nature. It evaluates the degree to which people perceive themselves as a part of the natural world and the extent to which they appreciate and value nature in their lives. Respondents are asked to rate their agreement with each statement on a Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The scores are then totaled to provide an overall measure of an individual's connection to nature.

    Measured: change from baseline at 0 to 8 weeks

  10. Social Loneliness and Isolation (ÉSUL)

    The Échelle de Solitude de l'Université Laval (ÉSUL) is a French-language adaptation of the UCLA Loneliness Scale, developed and validated in Quebec. It is a 20-item self-report questionnaire designed to assess perceived loneliness and social isolation. Each item is rated on a 4-point Likert scale ranging from "Never" to "Often," with higher scores indicating greater feelings of loneliness. The ESUL is commonly used in research and clinical settings involving French-speaking populations.

    Measured: change from baseline at 0 to 8 weeks

  11. Interoceptive Awareness (MAIA-Fr)

    The Multidimensional Assessment of Interoceptive Awareness - French version (MAIA-Fr) is a validated French-language adaptation of the original MAIA questionnaire. It consists of 32 self-report items grouped into eight subscales that assess different dimensions of interoceptive body awareness, such as Noticing, Emotional Awareness, Self-Regulation, and Body Listening. Items are rated on a 6-point Likert scale ranging from "never" to "always," with higher scores indicating greater interoceptive awareness.

    Measured: change from baseline at 0 to 8 weeks

  12. Pain measures

    Pain measurement will be done using the Brain pain inventory (BPI) questionnaire. The interference items will be presented with 0-10 scales, with 0=no interference and 10=interferes completely.

    Measured: change from baseline at 0 to 8 weeks

  13. Social Provisions (SPS-10)

    The Social Provisions Scale-10 (SPS-10) is a shorter version of the original Social Provisions Scale (SPS). It is a brief self-report questionnaire designed to measure perceived social support across five dimensions. The SPS-10 is derived from the longer SPS but consists of a subset of items that capture key aspects of social support.

    Similar to the original SPS, respondents rate their agreement with each item on a Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The SPS-10 provides a quick and efficient way to assess an individual's perceived social support network and their satisfaction with various aspects of their social relationships.

    Measured: change from baseline at 8 to 12 weeks

  14. Disability related to low back pain (RMDQ)

    The Roland-Morris Disability Questionnaire (RMDQ) is a widely used self-report measure designed to assess physical disability due to low back pain. It consists of 24 yes/no items related to daily physical activities and functional limitations caused by back pain. Each affirmative response scores one point, for a total score ranging from 0 (no disability) to 24 (maximum disability). Higher scores indicate greater functional impairment.

    Measured: change from baseline at 0 to 8 weeks

  15. Mood states (POMS-SF)

    The Profile of Mood States - Short Form (POMS-SF), French Version is a validated self-report questionnaire used to assess short-term changes in mood states. This version consists of 20 items rated on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"), and measures six mood dimensions: Anxiety (ANX), Depression (DEP), Anger (COL), Vigor (VIG), Fatigue (FAT), and Confusion (CON). Subscale scores are summed separately, with higher scores indicating greater intensity of the respective mood state, except for Vigor, where higher scores reflect better mood. This version, adapted and validated in French by Fillion \& Gagnon (1999), is administered before and after each intervention session to assess immediate psychological effects.

    Measured: 8 weeks

  16. Pain catastrophisation (PCS)

    The Pain Catastrophizing Scale (PCS) is a validated self-report questionnaire designed to assess catastrophic thinking related to pain. It consists of 13 items that measure three dimensions: rumination, magnification, and helplessness. Participants rate each item on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("all the time"). The total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. The PCS is widely used in both clinical and research settings to evaluate psychological responses to pain.

    Measured: change from baseline at 0 to 8 weeks

  17. Fear and beliefs regarded pain (FABQ)

    The Fear and Beliefs Questionnaire (FBQ) is a self-administered questionnaire designed to assess fear-avoidance beliefs and perceptions related to low back pain. It evaluates how individuals perceive the harmfulness of movement and physical activity, and how these beliefs may influence their behavior and functional limitations. The FBQ includes items rated on a Likert scale, with higher scores reflecting stronger fear-avoidance beliefs. It is commonly used in clinical and research settings to better understand the psychosocial factors contributing to chronic pain and disability.

    Measured: change from baseline at 0 to 8 weeks

Secondary outcomes (6)
  1. Functional mobility test (TUG)

    To assess mobility. Equipment: A stopwatch. Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.

    Measured: change from baseline at 0 to 8 weeks

  2. 5 times Sit-To-Stand (FTSTS)

    The Five Times Sit to Stand Test (5xSTS) is a standardized functional assessment used to evaluate lower limb strength, balance, and functional mobility. Participants are instructed to rise from a standard chair and sit back down five times as quickly as possible without using their arms. The total time to complete the five repetitions is recorded in seconds. This measure is commonly used to assess physical function and fall risk in older adults.

    Measured: change from baseline at 0 to 8 weeks

  3. Grip strength

    Jamar dynamometer to assess maximal isometric hand grip strength and frailty criteria. 3 trials of maximal contraction up 5 seconds. The best value is retained and corrected by body mass index from Fried classification.

    Measured: change from baseline at 0 to 8 weeks

  4. Walking speed on 10 metres

    Walking speed executed in 10 meter walking test. 2 trials and the best value in time seconds is retained for analysis.

    Measured: change from baseline at 0 to 8 weeks

  5. Postural control

    Measures of center of pressure (COP) using a force platform during different balance tasks

    Measured: change from baseline at 0 to 8 weeks

  6. Gait

    Gait parameters from GaitRite measurement: The participants will be asked to walk at normal and fast speeds on a GaitRite treadmill (GAI-TRite® Platinum Plus System 16' - 4.876 m, SN: Q209, CIR Systems Inc., Franklin, NJ, USA).

    Participants will perform each task twice. Main gait parameters will be used as main outcomes such as velocity in m/s.

    Measured: change from baseline at 0 to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start22 May 2025
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002853
Sponsor's protocol ID
2025-1991
Acronym
PARC-2
Status last verified
Nov 2026
First submitted
24 May 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Suh JH, Kim H, Jung GP, Ko JY, Ryu JS. The effect of lumbar stabilization and walking exercises on chronic low back pain: A randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(26):e16173. doi: 10.1097/MD.0000000000016173.

    PubMed 31261549
  • Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.

    PubMed 34580864
  • Fernandez-Rodriguez R, Alvarez-Bueno C, Cavero-Redondo I, Torres-Costoso A, Pozuelo-Carrascosa DP, Reina-Gutierrez S, Pascual-Morena C, Martinez-Vizcaino V. Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. J Orthop Sports Phys Ther. 2022 Aug;52(8):505-521. doi: 10.2519/jospt.2022.10671. Epub 2022 Jun 19.

    PubMed 35722759
  • Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032.

    PubMed 20494814
  • Brumitt J, Matheson JW, Meira EP. Core stabilization exercise prescription, part I: current concepts in assessment and intervention. Sports Health. 2013 Nov;5(6):504-9. doi: 10.1177/1941738113502451.

    PubMed 24427424
  • Han JW, Choi H, Jeon YH, Yoon CH, Woo JM, Kim W. The Effects of Forest Therapy on Coping with Chronic Widespread Pain: Physiological and Psychological Differences between Participants in a Forest Therapy Program and a Control Group. Int J Environ Res Public Health. 2016 Feb 24;13(3):255. doi: 10.3390/ijerph13030255.

    PubMed 26927141
  • Li Q, Morimoto K, Kobayashi M, Inagaki H, Katsumata M, Hirata Y, Hirata K, Shimizu T, Li YJ, Wakayama Y, Kawada T, Ohira T, Takayama N, Kagawa T, Miyazaki Y. A forest bathing trip increases human natural killer activity and expression of anti-cancer proteins in female subjects. J Biol Regul Homeost Agents. 2008 Jan-Mar;22(1):45-55.

    PubMed 18394317
  • Li Q. Effects of forest environment (Shinrin-yoku/Forest bathing) on health promotion and disease prevention -the Establishment of "Forest Medicine". Environ Health Prev Med. 2022;27:43. doi: 10.1265/ehpm.22-00160.

    PubMed 36328581
  • Irvine KN, Fisher D, Currie M, Colley K, Warber SL. A Nature-Based Intervention for Promoting Physical Activity in Older Adults: A Qualitative Study Using the COM-B Model. Int J Environ Res Public Health. 2024 Jun 27;21(7):843. doi: 10.3390/ijerph21070843.

    PubMed 39063420
  • Frumkin H, Bratman GN, Breslow SJ, Cochran B, Kahn PH Jr, Lawler JJ, Levin PS, Tandon PS, Varanasi U, Wolf KL, Wood SA. Nature Contact and Human Health: A Research Agenda. Environ Health Perspect. 2017 Jul 31;125(7):075001. doi: 10.1289/EHP1663.

    PubMed 28796634
  • Zhang SK, Gu ML, Zhang T, Xu H, Mao SJ, Zhou WS. Effects of exercise therapy on disability, mobility, and quality of life in the elderly with chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res. 2023 Jul 19;18(1):513. doi: 10.1186/s13018-023-03988-y.

    PubMed 37468931
  • Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.

    PubMed 21665125
  • Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.

    PubMed 30546064
  • Dionne CE, Dunn KM, Croft PR. Does back pain prevalence really decrease with increasing age? A systematic review. Age Ageing. 2006 May;35(3):229-34. doi: 10.1093/ageing/afj055. Epub 2006 Mar 17.

    PubMed 16547119
  • da Silva RA, Vieira ER, Carvalho CE, Oliveira MR, Amorim CF, Neto EN. Age-related differences on low back pain and postural control during one-leg stance: a case-control study. Eur Spine J. 2016 Apr;25(4):1251-7. doi: 10.1007/s00586-015-4255-9. Epub 2015 Oct 1.

    PubMed 26428907

Questions about this trial

What is this clinical trial studying?

A study testing Nature-based Intervention in people with Chronic Disease and Chronic Pain (Back / Neck), run by Université du Québec à Chicoutimi at 1 site in Canada.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention rate (time frame: 8 weeks). The study lists 17 primary outcomes in all. 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 NCT07002853, which also lists 31 linked publications.

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 5 Nov 2026.

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