Low Back PainNCT04055545
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
A study testing HIIT and MICT in people with Low Back Pain, run by Cerini Tamara at 1 site in Switzerland.
Trial summary
The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other. Read more about this study
- Who is it for?
- Ages 29 to 69 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- HIIT and MICT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2019to 13 Mar 2020
- 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 29 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oswestry disability index (ODI) Score ≥ 14%
- Low back pain for at least 3 months.
- Declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak.
- Good understanding of German or English, written and spoken.
- Age between 29 - 69
- No or stopped physical therapy.
Who cannot join
- Pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis.
- Known pregnancy.
- Previous low back spinal surgery in the last 2 years.
- Tumour, spinal stenosis, spinal fractures or radiculopathy.
- Comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 12 Week High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects: a Randomized Single-blinded Feasibility Study
The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.
Read the detailed description
The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an investigation about its effects.
However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to integrate it in the daily practise and future research.
In a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week HIIT programm.
- Conditions
- Low Back Pain
- Being tested
- HIIT, MICT
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
Also called high intensity interval training
- 5 min. warm up
- 10 × 60 seconds burst
- 60 seconds recovery after each burst
- Burst phase: HRR >90%
- Recovery phase: HRR btw. 30-39%
- 5 min. cool down
MICTOther
Also called moderate intensiv continuous training
- 5 min. warm up
- 20 min. continuous cycling: HRR btw. 40% - 59%
- 5 min. cool down
| Study group | Role | What they receive |
|---|---|---|
| MICT | Active comparator | Not described Receives: Other: MICT |
| HIIT | Active comparator | Not described Receives: Other: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Difference in training adherence rate between HIIT and MICT. The adherence rate will be calculated in the amount of days a patient trained versus the total days they were scheduled to train.
Measured: 13 weeks
Secondary outcomes (4)
Enjoyability
Likert scale from -3 to +3. -3 = I hate it, 0 = Neutral, +3 = I enjoy it.
Measured: 13 week
Willingness to continue the training
Likert scale from -3 to +3. -3 = Very low, 0 = Neutral, +3 = Very high.
Measured: 13 weeks
Number of Adverse Events & Dropout rate
Dropout rate and adverse events connected with the training
Measured: 13 weeks
Recruited rate
Screened patients in relation with the number of recruited patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start25 Sep 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerini Tamara
- Sponsor type
- University, hospital or other
- Collaborators
- Schulthess Klinik
- Responsible party
- Sponsor-investigator, Cerini Tamara, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055545
- Sponsor's protocol ID
- HIITvsMICT
- Status last verified
- Apr 2020
- First submitted
- 10 Aug 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerini T, Hilfiker R, Riegler TF, Felsch QTM. 12 weeks high intensity interval training versus moderate intensity continuous training in chronic low back pain subjects: a randomised single-blinded feasibility study. Arch Physiother. 2022 May 2;12(1):12. doi: 10.1186/s40945-022-00136-3.
PubMed 35491417
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Week High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects: a Randomized Single-blinded Feasibility Study
- ClinicalTrials.gov ID
- NCT04055545
- Acronym / sponsor ID
- HIITvsMICT
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cerini TamaraUniversity, hospital or other
- Collaborators
- Schulthess Klinik
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 13 Aug 2019 (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 current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.
Detailed description
The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an investigation about its effects.
However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to integrate it in the daily practise and future research.
In a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week HIIT programm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICT | Active comparator | Other: MICT |
| HIIT | Active comparator | Other: HIIT |
Who may qualify
- Ages
- 29 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Oswestry disability index (ODI) Score ≥ 14%
- Low back pain for at least 3 months.
- Declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak.
- Good understanding of German or English, written and spoken.
- Age between 29 - 69
Key exclusion criteria (5 listed)
- Pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis.
- Known pregnancy.
- Previous low back spinal surgery in the last 2 years.
- Tumour, spinal stenosis, spinal fractures or radiculopathy.
- Comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.
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 |
|---|---|---|
| HIITAlso: high intensity interval training* 5 min. warm up * 10 × 60 seconds burst * 60 seconds recovery after each burst * Burst phase: HRR >90% * Recovery phase: HRR btw. 30-39% * 5 min. cool down | Other | HIIT |
| MICTAlso: moderate intensiv continuous training* 5 min. warm up * 20 min. continuous cycling: HRR btw. 40% - 59% * 5 min. cool down | Other | MICT |
Primary outcome
Adherence
Time frame: 13 weeks
Difference in training adherence rate between HIIT and MICT. The adherence rate will be calculated in the amount of days a patient trained versus the total days they were scheduled to train.
4 secondary outcomes
Enjoyability
Time frame: 13 week
Willingness to continue the training
Time frame: 13 weeks
Number of Adverse Events & Dropout rate
Time frame: 13 weeks
Recruited rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 35491417Cerini T, Hilfiker R, Riegler TF, Felsch QTM. 12 weeks high intensity interval training versus moderate intensity continuous training in chronic low back pain subjects: a randomised single-blinded feasibility study. Arch Physiother. 2022 May 2;12(1):12. doi: 10.1186/s40945-022-00136-3.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and MICT in people with Low Back Pain, run by Cerini Tamara at 1 site in Switzerland.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055545, which also lists 1 linked publication.
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 14 Apr 2020.