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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Valida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    set of questionnaires to be filled out once

Treatment groups

148 Participants
are divided into 1 treatment group
Group A: patients with chronic low back pain1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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