Individual and Group Exercise Program for Industrial Workers With CANS: Randomized Controlled Trial

NCT02188030 | Unknown DMC

• 1 other identifier: 480.968
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is double-blinded RCT, whose aim is to assess if an individual exercise program is more effective to reduce complaints in neck, shoulders and arms that an group exercise program, in industrial workers. The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care.

Conditions

Musculoskeletal Disorder of the Neck

Keywords

musculoskeletal symptom; industrial workers; physical-activity program; resistance training; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity during and after treatment

  Numeric Pain Rating Scale (NPRS) assesses the pain intensity levels perceived by the patient using likert 11-point scale (ranging from 0 to 10), with 0 representing "no pain" and 10 representing "the worst possible pain". The participants will be instructed to report the level of pain intensity in the last seven days.

  6th and 12th week after the start of treatment

Secondary Outcomes (2)

• Global Impression of Recovery

  6th and 12th week after treatment

• Disability

  Baseline, 6th and 12th week after treatment

Study Arms (2)

Group Exercise Training (GET).

ACTIVE COMPARATOR

Group Exercise Program. The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum 12. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.

Other: Group Exercise Program

Individual Exercise Training

ACTIVE COMPARATOR

Individual Exercise Program. The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al. and Sundstrup et al . During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.

Other: Individual Exercise Program

Interventions

Group Exercise Program OTHER

The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.

Group Exercise Training (GET).

Individual Exercise Program OTHER

The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al.3 and Sundstrup et al4. During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload5. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.

Individual Exercise Training

Eligibility Criteria

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

You may qualify if:

• Clinical Diagnose of nontraumatic complaints of the arm, neck or shoulder with minimum intensity of 4 points on the visual analogue pain scale1, for at least 6 weeks2.

You may not qualify if:

• Participants with contraindication to physical exercise
• Participants who had been diagnosed with cervical disc hernia; shoulder instability; fractures; frozen shoulder; systemic diseases such as rheumatoid arthritis or diabetes; neurological diseases or other severe medical or psychiatric disorders

Sponsors & Collaborators

• Rosimeire Simprini Padula: lead

Study Sites (1)

União Metropolitana de Ensino e Cultura (UNIME)

Itabuna, Estado de Bahia, 45600-000, Brazil

RECRUITING

Study Officials

• Rosimeire Padula, Doctor

  Universidade Cidade de São Paulo (UNICID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Luiza Comper, Msc.

CONTACT

+557388220614; marialuizacaires21@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2014

Record last verified: 2014-06

Locations

BR (1)