Impact of Leisure Activities on Quality of Life in Low Back Pain (LEAP-BACK)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 148

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1082
    • Centre Hospitalier Valisana - site VALIDA
    • Contact: Samar M Hatem; Phone Number: +32 2 4824081; Email: samar.hatem@valisana.be
    • Principal Investigator: Anaïs Aubry
  • Charleroi, Belgium
    • Grand Hôpital de Charleroi
    • Contact: Olivier Nonclercq; Phone Number: +32 60 111900; Email: olivier.nonclercq@ghdc.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with chronic low back pain	Other: Questionnaires; set of questionnaires to be filled out once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at inclusion
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.	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.	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.	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.	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.	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Valida

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 26-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No