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.
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
- Recruiting
Centre Hospitalier Valisana - site VALIDA
Brussels, 1082
Samar M Hatem, +32 2 4824081, samar.hatem@valisana.be
Anaïs Aubry
- Not yet recruiting
Grand Hôpital de Charleroi
Charleroi
Olivier Nonclercq, +32 60 111900, olivier.nonclercq@ghdc.be
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.
- Conditions
- Chronic Low Back Pain
- 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 group | Role | What they receive |
|---|---|---|
| patients with chronic low back pain | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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.
- First posted12 Mar 2026
- Study start1 Jun 2026
- Primary completionMay 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Valida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar HATEM, Centre Hospitalier Valida
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Leisure Activities on Quality of Life in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07467499
- Acronym / sponsor ID
- LEAP-BACK / 26-001
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Centre Hospitalier ValidaUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 Mar 2026 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with chronic low back pain | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Questionnairesset of questionnaires to be filled out once | Other | patients with chronic low back pain |
Primary outcome
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
6 secondary outcomes
Nottingham Leisure Questionnaire
Time frame: at inclusion
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: at inclusion
Simple Physical Activity Questionnaire (SIMPAQ)
Time frame: at inclusion
Leisure Motivation Scale (LMS-28)
Time frame: at inclusion
Hospital Anxiety and Depression Scale (HADS)
Time frame: at inclusion
Oswestry Disability Index (ODI)
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
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.