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Chronic Low Back PainLEAP-BACKNCT07467499

Impact of Leisure Activities on Quality of Life in Low Back Pain

An observational study of Chronic Low Back Pain, run by Centre Hospitalier Valida at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Chronic low back negatively impacts upon physical and mental quality of life. The relationship between pain, physical function and physical activity levels has been largely studied in low back pain. However the impact of leisure activities on the quality of life of patients with low back pain is unknown. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Questionnaires
How many people
148 participants
Where
2 sitesBelgium
Study dates
1 Jun 2026to Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: The study population will consist of patients with chronic low back pain. Chronic low back pain is defined as pain located in the lumbar region (between the lower edge of the sides and the gluteal fold) that is persistent or recurrent for at least 12 weeks.

Who may be able to join

  • Age ≥ 18 years.
  • Diagnosis of chronic low back pain by a physician, defined as pain located in the lumbar region (between the lower edge of the sides and the gluteal fold) that is persistent or recurrent for at least 12 weeks.
  • Ability to complete questionnaires in French, informed consent.
  • Signed informed consent before any participation in the study.

Who cannot join

  • Recent lumbar surgery (< 6 months) or current surgical indication.
  • Severe neurological condition (stroke, neurodegenerative diseases, head injury, etc.), active cancer, pregnancy.
  • Severe psychiatric condition.
  • Participation in another clinical trial within the last 6 months.
  • Inability to understand French or to complete the questionnaires independently.
  • Refusal to participate.
  • Refusal to sign the informed consent form.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium2 sites, 2 recruiting
  • Centre Hospitalier Valisana - site VALIDA

    Brussels, 1082

    Samar M Hatem, +32 2 4824081, samar.hatem@valisana.be

    Anaïs Aubry

    Recruiting
  • Grand Hôpital de Charleroi

    Charleroi

    Olivier Nonclercq, +32 60 111900, olivier.nonclercq@ghdc.be

    Not yet recruiting

Other trials in Belgium

About this study

Official title: Impact of Leisure Activities on Quality of Life in Patients With Chronic Low Back Pain

Chronic low back negatively impacts upon physical and mental quality of life. The relationship between pain, physical function and physical activity levels has been largely studied in low back pain. However the impact of leisure activities on the quality of life of patients with low back pain is unknown. In other patient populations, a high engagement with leisure activities has been associated with better health-related quality of life.

Being tested
Questionnaires

What participants receive

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

  • QuestionnairesOther

    set of questionnaires to be filled out once

Study groups in NCT07467499
Study groupRoleWhat they receive
patients with chronic low back painNot described
Receives: Other: Questionnaires

What is being measured

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

  1. Spearman rank correlation between leisure activity level assessed by Nottingham Leisure Questionnaire and quality of life assessed by Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

    Measured: at inclusion

Secondary outcomes (6)
  1. Nottingham Leisure Questionnaire

    A 30-item, self-report assessment tool primarily designed to measure leisure activity participation in adults, particularly stroke survivors, but also used for other populations. It evaluates the frequency of various social and solitary activities (indoor/outdoor) over the previous few weeks using a 3-point scale: 0 (never), 1 (occasionally), and 2 (regularly). The total score ranges from a minimum of 0 to a maximum of 60. Higher scores mean engaging more regularly in leisure practice.

    Measured: at inclusion

  2. Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

    A, 29-question, patient-reported survey measuring health-related quality of life across seven core domains: physical function, fatigue, pain interference, depression, anxiety, sleep disturbance, and social roles. Developed by the NIH, it includes a 0-10 pain intensity item and four questions per domain. Scores are transformed in a T-score with a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates a better outcome than average.

    Measured: at inclusion

  3. Simple Physical Activity Questionnaire (SIMPAQ)

    A 5-item clinical tool designed to assess physical activity among populations at high risk of sedentary behaviour.T he Simple Physical Activity Questionnaire (SIMPAQ) is scored by calculating the average daily time (in hours or minutes) spent on five categories over the past week: time in bed, sedentary behavior, walking, structured exercise, and incidental activity. These five components should sum to approximately 24 hours per day, which provides a check for reporting accuracy. Time spent on physical activity is calculated by summing walking and structured exercise. The lowest score is 0 hours and the highest 24 hours. Higher scores means more time spent exercising.

    Measured: at inclusion

  4. Leisure Motivation Scale (LMS-28)

    This scale assesses people's motivation for engaging in their leisure activities. It assesses 7 types of motivation : intrinsic motivation toward knowledge, accomplishment and stimulation, as well as external, introjected and identified regulations and amotivation. It contains 28 items (4 items for each of the 7 sub-scales) assessed on a 7-point scale. Scores for each subscale are summed to determine which motivations (e.g., intellectual, social, competence, stimulus-avoidance) drive the behavior (ranging from 4 to 28 points). The highest scoring subscale identifies the primary reason for a person's engagement in leisure activities.

    Measured: at inclusion

  5. Hospital Anxiety and Depression Scale (HADS)

    A 14-item, self-report screening tool (7 questions for anxiety, 7 for depression) used to detect emotional distress in patients with physical health conditions. It is scored by summing responses to the 14 items , each rated 0-3. Subscales (HADS-A and HADS-D) range from 0 to 21. Scores of 0-7 are normal, 8-10 mild, 11-14 moderate, and 15-21 severe. Higher scores indicate higher distress.

    Measured: at inclusion

  6. Oswestry Disability Index (ODI)

    A self-administered questionnaire that measures a patient's functional disability caused by low back pain. It consists of 10 items assessing daily activities (e.g., pain, lifting, walking), with scores from 0-100% representing disability levels from minimal to bedbound.

    Measured: at inclusion

Timeline

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

  1. First posted12 Mar 2026
  2. Study start1 Jun 2026
  3. Primary completionMay 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07467499
Sponsor's protocol ID
26-001
Acronym
LEAP-BACK
Status last verified
Sep 2026
First submitted
4 Mar 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Low Back Pain, run by Centre Hospitalier Valida at 2 sites in Belgium.

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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spearman rank correlation between leisure activity level assessed by Nottingham Leisure Questionnaire and quality of life assessed by Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) (time frame: at inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Sep 2026.

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LEAP-BACK Clinical Trial NCT07467499 | AzTrials