Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain

NCT ID: NCT04915547

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-01

Brief Summary

The main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain.

Detailed Description

The main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain. The evaluation of feasibility will be related to: (1) blinding the evaluator to allocate the groups; (2) eligibility and recruitment rates; (3) acceptability of random allocation to a group; (4) possible contamination between groups; (5) adherence to treatment; (6) satisfaction with the treatment; and (7) difficulty in understanding the information provided by the physiotherapist.

Conditions

Low Back Pain; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group-Based Exercise

The group-based exercise (GBE) programme will be delivered by a physiotherapist. The GBE comprises three sessions per week of group-based exercise in a local community centre, for 8 weeks.

Group Type: EXPERIMENTAL

Group-Based Exercise

Intervention Type: OTHER

Each group session will consist of 10 to 18 participants and each exercise session will last 60 minutes and consist of four stages: (1) five minutes warm up (i.e. self-regulated walk); (2) twenty minutes of moderate intensity walking (3) thirty minutes of resistance training for the major muscles of the leg, trunk and arm and balance exercises that progress in difficulty; (4) five-minute cool down period (i.e. self-regulated walk). The exercise intensity will be assessed by one of the following criteria: 1) Resistance training - Point of volitional fatigue. Walking - Somewhat difficult (Borg at 3 to 4). The intensity will be increased according to the ACSM guideline.

The exercise was set up based on changes in instruments of evaluation of the older peoples as, Berg Balance Scale; Dynamic Gait Index and Timed Up and Go. In addition, exercises commonly used in primary health care groups. The protocol will take place in a gymnasium and will be supervised by a trained instructor.

Control Group

Participants randomly allocated to the control group will remain on a waiting list. In addition, weekly contact will be made to ensure that they do not start treatment during the study protocol. After the end of the study, participants randomly allocated to the control group will receive the same intervention as the Group-Based Exercise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group-Based Exercise

Each group session will consist of 10 to 18 participants and each exercise session will last 60 minutes and consist of four stages: (1) five minutes warm up (i.e. self-regulated walk); (2) twenty minutes of moderate intensity walking (3) thirty minutes of resistance training for the major muscles of the leg, trunk and arm and balance exercises that progress in difficulty; (4) five-minute cool down period (i.e. self-regulated walk). The exercise intensity will be assessed by one of the following criteria: 1) Resistance training - Point of volitional fatigue. Walking - Somewhat difficult (Borg at 3 to 4). The intensity will be increased according to the ACSM guideline.

The exercise was set up based on changes in instruments of evaluation of the older peoples as, Berg Balance Scale; Dynamic Gait Index and Timed Up and Go. In addition, exercises commonly used in primary health care groups. The protocol will take place in a gymnasium and will be supervised by a trained instructor.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older people aged 60 years old or over who have nonspecific LBP, defined as pain below the costal margin and above the lower gluteal folds, with or without referred leg pain for at least 3 months.
• Disability with score 4/24 in Roland-Morris Disability Questionnaire or higher and persistent back pain of pain 3/10 or higher.

Exclusion Criteria

• Suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder);
• Radiculopathy (i.e. presence of 2 of the 3 following criteria: strength, reflex or sensation alterations compatible with lumbosacral nerve root compression);
• Previous history of spinal surgery; scheduled for major surgery during the study or at the follow up period;
• Any of the contraindications to exercise listed on page 103 of the American College of Sports Medicine (ACSM) guidelines.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Letícia Soares Fonseca

Role: PRINCIPAL_INVESTIGATOR

Federal University of the Valleys of Jequitinhonha and Mucur

Central Contacts

Vinicius C Oliveira

Role: CONTACT

vcunhaoliveira@gmail.com

31995696214

Other Identifiers

30042021

Identifier Type: -

Identifier Source: org_study_id