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Completed

NCT Number: NCT04000685

The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain

Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındag, 06100, Turkey (Türkiye)

About this study

Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-specific low back pain
  • Must be pain at least 3 months

Exclusion criteria

  • History of any lumbar spine surgery
  • Presence of neurological deficit
  • Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training.
  • The presence of persistent severe pain
  • Pain below the knee
  • Severe/progressive scoliosis
  • Spinal stenosis
  • Spondylolisthesis
  • Cancer
  • Diabetes
  • Metabolic syndrome
  • Inflammatory, infectious or tumoral disease of the vertebra

Treatment and study plan

Yoga Exercise Program

Other

Yoga exercise program will be applied two sessions per week, totally eight week.

Spinal stabilization exercise program

Other

Spinal stabilization exercise program will be applied two sessions per week, totally eight week.

Aerobic walking program

Other

Aerobic walking program will be applied two sessions per week, totally eight week.

Primary outcomes

  1. Changes in pain severity

    Time frame: change from baseline in pain severity at 8 weeks

    Patients' average resting, activity and night pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.

  2. Changes of functional status

    Time frame: change from baseline in functional status at 8 weeks

    Patient's permanent functional disability measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound.

Secondary outcomes

  1. Changes in quality of life

    Time frame: Change from baseline in life quality levels at 8 weeks

    Health-related quality of life assessed by Nottingham Health Profile (NHP). The NHP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. Lower scores denoting a better quality of life.

  2. Changes in gait parameters

    Time frame: Change from baseline in gait parameters at 8 weeks

    Gait assessment will be recorded with OptoGait for one minute while participants walked their preferred speed on the treadmill. Patients asked to walk on level surface. Assessment were recorded during one minute.

  3. Changes in metabolic capacity

    Time frame: Change from baseline in metabolic capacity at 8 weeks

    Metabolic capacity testing will be performed according to the Modified Bruce protocol on the Treadmill. At 3 minute intervals, the inclination increase by %2 with a concomitant increase in speed.

  4. Changes in cognitive level

    Time frame: Change from baseline in cognitive level at 8 weeks

    The Montreal Cognitive Assessment Questionnaire (MoCA) will be used to assess the cognitive levels of individuals. MoCA was developed as a rapid screening test for mild cognitive impairment. MoCA assesses various cognitive functions such as attention and concentration, creative functions, memory, language, visual structuring skills, abstract thinking, computation and orientation. The application of MoCA takes about 10 minutes. The maximum total score of the test is 30. A score of 21 or above is considered normal.

  5. Changes in alexithymia

    Time frame: Change from baseline in alexithymia at 8 weeks

    The alexithymia will be assessed by the Toronto Alexithymia Scale (TAS). The scale is a Likert-type self-assessment scale consisting of 20 items and scored between 1-5. Difficulties in recognizing emotions (TAS-1), difficulty in speaking emotions (TAS-2), extroverted thinking (TAS-3) subscales. The individual is asked to select the best option for each item from "Never", "Rarely", "Sometimes", "Often" and "Always". The higher the score, the higher the level of alexithymia.

  6. Changes in kinesiophobia.

    Time frame: Change from baseline in kinesiophobia at 8 weeks

    Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain.This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. The higher the score, the higher the kinesiophobia.

  7. Changes in back awareness

    Time frame: Change from baseline in back awareness at 8 weeks

    The Fremantle Back Awareness Questionnaire will be used to evaluate how individuals perceive the back according to their body. The questionnaire includes 9 questions that measure how individuals perceive their back according to their body and how they perceive their body position. Questions is answered Likert type as "0" I never feel like this, "4" always or often feel like this.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2019
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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