Low Back PainNCT04915547
Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain
A study testing Group-Based Exercise in people with Low Back Pain and Back Pain, run by Federal University of the Valleys of Jequitinhonha and Mucuri.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Low Back Pain, Back Pain
- What is being tested?
- Group-Based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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
- Being tested
- Group-Based Exercise
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-Based ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks from randomization
Eligibility and recruitment rates
Eligibility and recruitment rates
Measured: 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.
Measured: 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.
Measured: 8 weeks from randomization
Adherence to treatment
Adherence to treatment measured by frequency during the intervention
Measured: 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:
- 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
Measured: 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
Measured: 8 weeks from randomization
Secondary outcomes (6)
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.
Measured: 8 weeks from randomization
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).
Measured: 8 weeks from randomization
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).
Measured: 8 weeks from randomization
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.
Measured: 8 weeks from randomization
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.
Measured: 8 weeks from randomization
Frequency of falls
Frequency of falls assessed by the number of falls during the study period
Measured: 8 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Letícia Soares Fonseca, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915547
- Sponsor's protocol ID
- 30042021
- Status last verified
- May 2021
- First submitted
- 15 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04915547
- Acronym / sponsor ID
- 30042021
- Conditions
- Low Back Pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-Based Exercise | Experimental | Other: Group-Based ExerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-Based ExerciseEach 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. | Other | Group-Based Exercise |
Primary outcome
Feasibility of blinding the assessor
Time frame: 8 weeks from randomization
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.
Eligibility and recruitment rates
Time frame: 8 weeks from randomization
Eligibility and recruitment rates
Acceptability of random allocation to a treatment group
Time frame: 8 weeks from randomization
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
Time frame: 8 weeks from randomization
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
Time frame: 8 weeks from randomization
Adherence to treatment measured by frequency during the intervention
Satisfaction with the treatment
Time frame: 8 weeks from randomization
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
Difficulty in understanding the information provided by the physiotherapist
Time frame: 8 weeks from randomization
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
6 secondary outcomes
Pain intensity
Time frame: 8 weeks from randomization
Disability
Time frame: 8 weeks from randomization
Fear of falling
Time frame: 8 weeks from randomization
Level of physical activity
Time frame: 8 weeks from randomization
Global perception of recovery
Time frame: 8 weeks from randomization
Frequency of falls
Time frame: 8 weeks from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Letícia Soares Fonseca principal investigator
Federal University of the Valleys of Jequitinhonha and Mucur
Questions about this trial
What is this clinical trial studying?
A study testing Group-Based Exercise in people with Low Back Pain and Back Pain, run by Federal University of the Valleys of Jequitinhonha and Mucuri.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vinicius C Oliveira (31995696214, vcunhaoliveira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of blinding the assessor (time frame: 8 weeks from randomization). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.