CClinicalTrials.gg
RecruitingNCT07467499LEAP-BACKUpdated Sep 15, 2026

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

An observational study in Chronic Low Back Pain, sponsored by Centre Hospitalier Valida. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Centre Hospitalier Valida · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
148
Ages
18 Years and older
Sex
All
01

Study 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. In other patient populations, a high engagement with leisure activities has been associated with better health-related quality of life.

02

Conditions studied

  • Chronic Low Back Pain
03

In context

Lead sponsor

Centre Hospitalier Valida is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
148 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with chronic low back pain

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

    set of questionnaires to be filled out once

06

What researchers measure

Primary outcomes

  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)

    Time frame: at inclusion

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: at inclusion

07

Study locations

1 of 2 sites recruiting
  • Centre Hospitalier Valisana - site VALIDA
    Brussels, 1082, Belgium
    Recruiting
  • Grand Hôpital de Charleroi
    Charleroi, Belgium
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07467499
Lead sponsor
Centre Hospitalier Valida
Responsible party
Samar HATEM (Co-investigator, Centre Hospitalier Valida) — Principal investigator
First posted
Mar 12, 2026
Start date
Jun 1, 2026
Primary completion
May 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion