Clinical trial NCT05449262: Time Course Effects of Functional Resistance Training on Fitness and Quality of Life Chronic Low Back Pain Patients
Official title: Time Course Effects of Functional Resistance Training on Fitness and Quality of Life in Patients With Nonspecific Chronic Low-back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Pain
disability
strength
quality of life
functional resistance training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is categorized according to its duration as acute (\<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (\>12 weeks). Low back pain can be either specific or non-specific. Specific low back pain is because of specific spinal pathologies including; Malignancy, Infection, Osteoporotic Collapse, Fracture, Ankylosing Spondylitis or other inflammatory disorders and Cauda equina compression. About 19 in 20 cases of acute (sudden onset) low back pain are classed as 'non-specific' It is called 'non-specific' because it is usually not clear what is actually causing the pain or there is no specific problem or disease that can be identified as to the cause of the pain.Functional Resistance Training (FRT) involves multiplanar and multi joint resistance exercises that simulate movement patterns from everyday life and sport Functional training exercises tend to focus more on the coordination, technique, posture, and core engagement instead of on training loads.

Detailed description: The lower back is also called the 'lumbosacral area' of the back. It is the part of the back between the bottom of the ribs and the top of the legs and is made up of the spine bones (vertebrae), discs, nerves, muscles and ligaments. Pain in this region is called low back pain. (1) Low back pain is categorized according to its duration as acute (\<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (\>12 weeks). About 19 in 20 cases of acute (sudden onset) low back pain are classed as 'non-specific' It is called 'non-specific' because it is usually not clear what is actually causing the pain or there is no specific problem or disease that can be identified as to the cause of the pain. It is said that cause may be a sprain (an over-stretch) of a ligament or muscle, minor problem with the disc between two vertebrae, or a minor problem with a small 'facet' joint between two vertebrae. It is not possible to identify these causes of the pain by tests. Therefore, it is usually impossible to say exactly where the pain is coming from, or exactly what is causing the pain. Sometimes a pain may develop immediately after lifting something heavy, or after an awkward twisting movement. Sometimes it can develop for no apparent reason. Some people just wake up one day with low back pain. Typically the pain is in one area of the lower back, but sometimes it spreads to one or both buttocks or thighs. Non-specific low back pain is 'mechanical' in the sense that it varies with posture or activity. In a small number of cases the pain persists for several months or longer. This is called chronic back pain. There is no test that can prove or confirm non-specific low back pain.

Non-specific low back pain is classed as chronic (persistent) if it lasts longer than six weeks. In some people it lasts for months, or even years. Symptoms may be constant. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide.

The ACSM defines functional RT (FRT) as activities involving multiple muscle, joint, and planar activities that are closely related to activities of daily living, combining upper and lower body movements to use more of the body in each movement. Few studies have examined FRT, though initial results suggest that FRT is associated with higher caloric expenditure and similar muscular strength, endurance, and gains in flexibility compared with a TRT program.

Functional training is becoming increasingly popular within the fitness industry and has been considered to be a better alternative than traditional resistance training for improving various measures of muscular fitness including strength, endurance, coordination and balance. The verb form of the word "function" pertains to the performance of an action, work or activity. Thus, exercise training programs that are deemed to be "functional" should be designed to mimic tasks or activities that occur in a person's daily life to make training adaptations more transferable. Engaging in regular RT provides physical, physiological and psychological health benefits while providing additional bone health benefits. Although RT has greatly increased in popularity, other types of training aside from traditional RT (TRT) have yet to be examined. One such type of training, ''functional fitness,'' is defined by the ACSM as the use of strength training to improve balance and ease of living, and was in the top 10 fitness trends in 2018.

Functional Resistance Training (FRT) involves multiplanar and multi joint resistance exercises that simulate movement patterns from everyday life and sport Functional training exercises tend to focus more on the coordination, technique, posture, and core engagement instead of on training loads. The goal of FRT is not hypertrophy but to promote a potential motor problem in order to train dynamic stabilization. Appropriate functional exercises are those in which the lumbo-pelvic region remains aligned within the neutral zone by co-contraction of the muscles of the trunk, while other demands executed with the extremities are simultaneously and successfully fulfilled. This method of training usually includes: a) spinal stabilization exercises; b) balance and proprioceptive exercises; c) flexibility exercises; d) resistance training exercises.

Functional RT may be more feasible and accessible due to the minimal equipment needed and the flexibility to be performed in and out of a typical gym setting.

Eligibility criteria: Inclusion Criteria:

* Patient having low back pain as a primary complaint, without associated leg pain;
* Chronic pain (\>= 3 months, \>= 3 days/week)
* non- specific (soft tissue in origin)
* Patient having no history of formal exercise training.
* Learning proper technique under expert supervision
* Postural stability (static/dynamic)

Exclusion Criteria:

* Receiving concurrent treatments from another practitioner for LBP
* Congenital deformities of spine
* Neurological conditions (neuropathy, radiculopathy)
* Musculoskeletal conditions (fractures, atrophy, weakness)
* Cardiovascular, Nephrological conditions
* Contraindications to exercise
* Involved in workers' compensation claims;
* Medications other than analgesics and NSAIDS

Primary outcomes:
measure: Visual analogue scale (VAS)for pain:
timeFrame: 6 weeks
measure: Visual analogue scale (VAS)for pain:
timeFrame: 12 weeks
measure: Oswestry Disability Index (ODI) for disability:
timeFrame: 6 weeks
measure: Oswestry Disability Index (ODI) for disability:
timeFrame: 12 weeks
measure: SHORT FORM-36 for HRQOL
timeFrame: 6 weeks
measure: SF-36 for HRQOL
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical fitness with flamingo test
timeFrame: 6 weeks
measure: Physical fitness with flamingo test
timeFrame: 12 weeks
measure: physical fitness with back endurance test:
timeFrame: 6 weeks
measure: physical fitness with back endurance test:
timeFrame: 12 weeks
measure: physical function with side bridge test
timeFrame: 6 weeks
measure: physical function with side bridge test
timeFrame: 12 weeks
measure: physical function with abdominal curl-up test
timeFrame: 6 weeks
measure: physical function with abdominal curl-up test
timeFrame: after 12 weeks
measure: physical function with 60-s squat test:
timeFrame: 6 weeks
measure: physical function with 60-s squat test:
timeFrame: 12 weeks
measure: Biofeedback pressure unit
timeFrame: 6 weeks
measure: Biofeedback pressure unit
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria Khalid, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References: