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

NCT04915547 | Unknown

• 1 other identifier: 30042021
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Back Pain

Outcome Measures

Primary Outcomes (7)

• Feasibility of blinding the assessor

  Feasibility of blinding will be assessed by asking the assessor two questions at the end of the follow-up assessment: 1. Did you receive any information that indicated to you which group the participant was assigned to? 2. How did you receive information about group assignment? Assessor's guess regarding group assignment group will be recorded for each participant. The responses will be coded as correct or incorrect guess. The frequency and relative rates of 'Yes' and 'No' as the answer to the first question will be computed, as will the frequency and relative rates of correct and incorrect guesses. Finally, reasons for guesses will be recorded as verbatim and reported.

  8 weeks from randomization

• Eligibility and recruitment rates

  Eligibility and recruitment rates

  8 weeks from randomization

• Acceptability of random allocation to a treatment group

  Outcome assessor will ask the participants if random allocation to one of the two treatment groups is acceptable to the participants. Responses will be recorded as 'Acceptable', 'Not acceptable' or 'No preference'. The frequencies of each response will be computed separately for each treatment condition.

  8 weeks from randomization

• Understanding possible contamination between the groups

  Measures to assess: Have you talked to other participants in this study about the intervention they are receiving? Has your attitude towards the intervention changed after talking to the participant (s) in the other group? Are any of the participants in the other group aware of the type of intervention you are receiving in this study? The frequencies of the participants who responded affirmatively to each question will be computed separately for each treatment condition.

  8 weeks from randomization

• Adherence to treatment

  Adherence to treatment measured by frequency during the intervention

  8 weeks from randomization

• Satisfaction with the treatment

  All the participants of the intervention group will be asked to respond an adapted version of the MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care at 1 week following treatment. The question asked will be: 1. Did my physiotherapist carefully explain the treatments I received? 2. Did my physiotherapist treat me respectfully? 3. Did my physiotherapist answer all my questions? n general, am I completely satisfied with the services I received from my physical therapist? Responses to this question are made on a five-point categorical scale 1='completely disagree'; 2='Disagree'; 3= 'Neutral'; 4=' Agree'; 5=' Completely agree'). The frequency of response for each question will be analyzed

  8 weeks from randomization

• Difficulty in understanding the information provided by the physiotherapist

  Difficulty in understanding the information provided by the physiotherapist measured on a five-point categorical scale: Very easy, Easy, Neither easy nor difficult, Difficult, Very difficult

  8 weeks from randomization

Secondary Outcomes (6)

• Pain intensity

  8 weeks from randomization

• Disability

  8 weeks from randomization

• Fear of falling

  8 weeks from randomization

• Level of physical activity

  8 weeks from randomization

• Global perception of recovery

  8 weeks from randomization

Study Arms (2)

Group-Based Exercise

EXPERIMENTAL

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.

Other: Group-Based Exercise

Control Group

NO INTERVENTION

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.

Interventions

Group-Based Exercise 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.

Group-Based Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Letícia Soares Fonseca

  Federal University of the Valleys of Jequitinhonha and Mucur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinicius C Oliveira

CONTACT

31995696214; vcunhaoliveira@gmail.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

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: June 7, 2021
• Study Start: March 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share