Back PainNCT06264102
Influence of Dalcroze Eurhythmics on Pains in Older Women
A study testing Physical exercise program in people with Back Pain and Headache, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- What is being tested?
- Physical exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 sitePoland
- Study dates
- 11 Jan 2019to 15 Jul 2019
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- female, 65+ years old, physical and mental state that allows them to participate in the exercise program (ability to follow the instructions), community dwelling
Who cannot join
- taking analgesics indelibly, Parkinson's or Alzheimer's disease, using social assistance or nursing care.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education
Poznan, Wielkopolska, 61-871
About this study
Official title: Effect of Dalcroze Eurhythmics' Physical Exercises on Headaches, Backaches, and Leg Pains in Older Women: a Randomized Controlled Trial
In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain.
Read the detailed description
Background. Body pain of various degrees and types can complicate human life. Regular physical exercise and good mental health can both have protective effects on the body and its physical health. Physical exercises may also, in some aspects, be particularly important for older women who experience varying degrees of headache, back pain, and/or leg pain chronically. The purpose of the study was to analyze the effects of the Dalcroze Eurhythmic Method on headaches, backaches, and leg pains among older women.
Methods. Sixty-two blinded participants with pain were randomized into two groups. Women (65 to 82 years old) who had reported the occurrence of headaches, backaches, or leg pains during the 3 months prior to the beginning of the randomized controlled trial study were identified. The participants in the pre-test and post-test used the 0-10 Numeric Pain Rating Scale to quantify their pain. Women from the experimental group participated for 3 months in the physical exercise program based on the Dalcroze Eurhythmics Method.
- Being tested
- Physical exercise program
- Keywords
- headache, elderly women, Dalcroze Eurhythmics, back pain, leg pain
- Medical subject headings
- Back Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programOther
Training sessions took place twice a week for 45 minutes each over a period of 12 weeks. Each training included rhythmic exercises using the Jaques-Dalcroze Eurhythmics (JDE) method with piano accompaniment and electronically played music. Training sessions were conducted by a JDE specialist.
Exercises with the use of this method consist mainly in the repetition of preset musical sequences using body movements. In addition to the physical layer, the cognitive layer was equally important: while performing a given movement exercise, participants often had to focus in order to react appropriately to additional tasks, such as changes in sound pitch and rhythm of the piece.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Physical exercises program Receives: Other: Physical exercise program |
| Control group | No intervention | Were advised not to change anything about their current lifestyle, and in particular not to undertake any new structured physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels before exercise program
Level of pains determined by numeric pain scale 1-10
Measured: From enrollment to the day before the start of the exercise program
Secondary outcomes (1)
Results of pain levels after exercise program
Level of pains determined by numeric pain scale 1-10
Measured: One month after completion of the exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start11 Jan 2019
- Primary completion8 Mar 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JANUSZ MACIASZEK, PROF, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264102
- Sponsor's protocol ID
- 2024/1/1
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dalcroze Eurhythmics' Physical Exercises on Headaches, Backaches, and Leg Pains in Older Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06264102
- Acronym / sponsor ID
- 2024/1/1
- Keywords
- headache, elderly women, Dalcroze Eurhythmics, back pain, leg pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 16 Feb 2024 (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.
In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain.
Detailed description
Background. Body pain of various degrees and types can complicate human life. Regular physical exercise and good mental health can both have protective effects on the body and its physical health. Physical exercises may also, in some aspects, be particularly important for older women who experience varying degrees of headache, back pain, and/or leg pain chronically. The purpose of the study was to analyze the effects of the Dalcroze Eurhythmic Method on headaches, backaches, and leg pains among older women.
Methods. Sixty-two blinded participants with pain were randomized into two groups. Women (65 to 82 years old) who had reported the occurrence of headaches, backaches, or leg pains during the 3 months prior to the beginning of the randomized controlled trial study were identified. The participants in the pre-test and post-test used the 0-10 Numeric Pain Rating Scale to quantify their pain. Women from the experimental group participated for 3 months in the physical exercise program based on the Dalcroze Eurhythmics Method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Physical exercise programPhysical exercises program |
| Control group | No intervention | –Were advised not to change anything about their current lifestyle, and in particular not to undertake any new structured physical activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- female, 65+ years old, physical and mental state that allows them to participate in the exercise program (ability to follow the instructions), community dwelling
Key exclusion criteria (1 listed)
- taking analgesics indelibly, Parkinson's or Alzheimer's disease, using social assistance or nursing care.
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 |
|---|---|---|
| Physical exercise programTraining sessions took place twice a week for 45 minutes each over a period of 12 weeks. Each training included rhythmic exercises using the Jaques-Dalcroze Eurhythmics (JDE) method with piano accompaniment and electronically played music. Training sessions were conducted by a JDE specialist. Exercises with the use of this method consist mainly in the repetition of preset musical sequences using body movements. In addition to the physical layer, the cognitive layer was equally important: while performing a given movement exercise, participants often had to focus in order to react appropriately to additional tasks, such as changes in sound pitch and rhythm of the piece. | Other | Intervention group |
Primary outcome
Pain levels before exercise program
Time frame: From enrollment to the day before the start of the exercise program
Level of pains determined by numeric pain scale 1-10
1 secondary outcome
Results of pain levels after exercise program
Time frame: One month after completion of the exercise program
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 16 Feb 2024.
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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.
JANUSZ MACIASZEK, PROF study director
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise program in people with Back Pain and Headache, run by Poznan University of Physical Education at 1 site in Poland.
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 1 inclusion and 1 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 16 Feb 2024. 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 Poland. 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?
Pain levels before exercise program (time frame: From enrollment to the day before the start of the exercise program). 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 16 Feb 2024.