Back to resultsEfficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain
Primary Purpose
Low Back Pain, Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group-Based Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group-Based Exercise
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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:
Did you receive any information that indicated to you which group the participant was assigned to?
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.
Eligibility and recruitment rates
Eligibility and recruitment rates
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.
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.
Adherence to treatment
Adherence to treatment measured by frequency during the intervention
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:
Did my physiotherapist carefully explain the treatments I received?
Did my physiotherapist treat me respectfully?
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
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
Secondary Outcome Measures
Pain intensity
Pain intensity measured with a Numerical Rating Scale from 0 to 10, , where 0 does not cause pain and 10 is the worst pain imaginable.
Disability
Disability measured with the Roland-Morris Disability Questionnaire. The questionnaire has 24 items with scores of 0 or 1 (yes or no) and the total ranges from zero (suggesting no disability) to 24 (severe disability).
Fear of falling
Fear of falling measured with the Falls Efficacy Scale- International. The Falls Efficacy Scale - International presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme concern).
Level of physical activity
Level of physical activity measured with the Physical Activity Rating scale. It is a progressive scale with scores from 0 to 7, in which the most appropriate option for the history of physical activity practice in the last 30 days should be selected.
Global perception of recovery
Global perception of recovery measured with Global Effect Perception Scale. This is a numerical scale where -3 represents "worse than ever", 0 "without modification" and 3 "completely recovered". A higher score means greater recovery from the condition.
Frequency of falls
Frequency of falls assessed by the number of falls during the study period
Full Information
NCT ID
NCT04915547
First Posted
May 15, 2021
Last Updated
May 31, 2021
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
1. Study Identification
Unique Protocol Identification Number
NCT04915547
Brief Title
Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain
Official Title
Efficacy of Group Exercise Program on Pain and Disability in Older People With Nonspecific Low Back Pain: Feasibility of a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group-Based Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Group-Based Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of blinding the assessor
Description
Feasibility of blinding will be assessed by asking the assessor two questions at the end of the follow-up assessment:
Did you receive any information that indicated to you which group the participant was assigned to?
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.
Time Frame
8 weeks from randomization
Title
Eligibility and recruitment rates
Description
Eligibility and recruitment rates
Time Frame
8 weeks from randomization
Title
Acceptability of random allocation to a treatment group
Description
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.
Time Frame
8 weeks from randomization
Title
Understanding possible contamination between the groups
Description
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.
Time Frame
8 weeks from randomization
Title
Adherence to treatment
Description
Adherence to treatment measured by frequency during the intervention
Time Frame
8 weeks from randomization
Title
Satisfaction with the treatment
Description
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:
Did my physiotherapist carefully explain the treatments I received?
Did my physiotherapist treat me respectfully?
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
Time Frame
8 weeks from randomization
Title
Difficulty in understanding the information provided by the physiotherapist
Description
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
Time Frame
8 weeks from randomization
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity measured with a Numerical Rating Scale from 0 to 10, , where 0 does not cause pain and 10 is the worst pain imaginable.
Time Frame
8 weeks from randomization
Title
Disability
Description
Disability measured with the Roland-Morris Disability Questionnaire. The questionnaire has 24 items with scores of 0 or 1 (yes or no) and the total ranges from zero (suggesting no disability) to 24 (severe disability).
Time Frame
8 weeks from randomization
Title
Fear of falling
Description
Fear of falling measured with the Falls Efficacy Scale- International. The Falls Efficacy Scale - International presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme concern).
Time Frame
8 weeks from randomization
Title
Level of physical activity
Description
Level of physical activity measured with the Physical Activity Rating scale. It is a progressive scale with scores from 0 to 7, in which the most appropriate option for the history of physical activity practice in the last 30 days should be selected.
Time Frame
8 weeks from randomization
Title
Global perception of recovery
Description
Global perception of recovery measured with Global Effect Perception Scale. This is a numerical scale where -3 represents "worse than ever", 0 "without modification" and 3 "completely recovered". A higher score means greater recovery from the condition.
Time Frame
8 weeks from randomization
Title
Frequency of falls
Description
Frequency of falls assessed by the number of falls during the study period
Time Frame
8 weeks from randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vinicius C Oliveira
Phone
31995696214
Email
vcunhaoliveira@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Letícia Soares Fonseca
Organizational Affiliation
Federal University of the Valleys of Jequitinhonha and Mucur
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain
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