Time Course Effects of Functional Resistance Training on Fitness and Quality of Life Chronic Low Back Pain Patients

NCT05449262 | Completed DMC

• 1 other identifier: REC 01054 Hafiza Sana Asad
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Pain; disability; strength; quality of life; functional resistance training

Outcome Measures

Primary Outcomes (6)

• Visual analogue scale (VAS)for pain:

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it is scientifically evident that VAS is a reliable and valid scale in aged more than 18 years. In many studies it is proved that VAS is a reliable scale but for validity it showed moderate to strong correlation for pain measurement. assessment to be done at base line after 6 weeks and after detraining of 6 weeks

  6 weeks

• Visual analogue scale (VAS)for pain:

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it is scientifically evident that VAS is a reliable and valid scale in aged more than 18 years. In many studies it is proved that VAS is a reliable scale but for validity it showed moderate to strong correlation for pain measurement. assessment to be done at base line after 12 weeks and after detraining of 12 weeks

  12 weeks

• Oswestry Disability Index (ODI) for disability:

  Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. The ODI can be used to assess both chronic and acute conditions of varying severity. It has high test-retest reliability and takes around 5min for a patient to complete. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.

  6 weeks

• Oswestry Disability Index (ODI) for disability:

  Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. The ODI can be used to assess both chronic and acute conditions of varying severity. It has high test-retest reliability and takes around 5min for a patient to complete. assessment to be done at base line after 12 weeks and after detraining of 12 weeks.

  12 weeks

• SHORT FORM-36 for HRQOL

  The Short form -36 covers eight different dimensions of HRQOL: physical functioning, social functioning, role limitations due to physical functioning (role functioning-physical), bodily gain, general mental health, role limitations due to emotional functioning (role functioning-emotional), vitality (energy and fatigue), and general health perception. Scores can be summed together from all domains with differing weightings to contribute to two summary scores, a physical component score and a mental component score. The study findings indicate that the SF-36 is a reliable and valid instrument for assessment of HRQoL in patients. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.

  6 weeks

• SF-36 for HRQOL

  The SF-36 covers eight different dimensions of HRQOL: physical functioning, social functioning, role limitations due to physical functioning (role functioning-physical), bodily gain, general mental health, role limitations due to emotional functioning (role functioning-emotional), vitality (energy and fatigue), and general health perception. Scores can be summed together from all domains with differing weightings to contribute to two summary scores, a physical component score and a mental component score. The study findings indicate that the SF-36 is a reliable and valid instrument for assessment of HRQoL in patients. assessment to be done at base line after 12 weeks and after detraining of 12 weeks.

  12 weeks

Secondary Outcomes (12)

• Physical fitness with flamingo test

  6 weeks

• Physical fitness with flamingo test

  12 weeks

• physical fitness with back endurance test:

  6 weeks

• physical fitness with back endurance test:

  12 weeks

• physical function with side bridge test

  6 weeks

Study Arms (2)

functional resistance training GROUP A

EXPERIMENTAL

Session of 45-60 min starting with Warm Up Exercise and stretching prior to therapy and cool-down and stretching after the training sessions

Other: functional resistance training GROUP A

functional resistance training GROUP B

EXPERIMENTAL

Session of 45-60 min starting with Warm Up Exercise and stretching prior to therapy and cool-down and stretching after the training sessions

Other: functional resistance training GROUP B

Interventions

functional resistance training GROUP A OTHER

Session of 45-60 min. Warm up prior to training Warm up 6-7 min of mild cardiovascular exercise followed by 3-4 min stretching Cool down post training A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching

functional resistance training GROUP A

functional resistance training GROUP B OTHER

Session of 45-60 min Warm up prior to training Warm up 6-7 min of mild cardiovascular exercise followed by 3-4 min stretching Cool down post training A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching

functional resistance training GROUP B

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Khalid, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: April 30, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 5, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)