NCT06264102

Brief 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. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 30, 2024

Last Update Submit

February 9, 2024

Conditions

Keywords

headacheelderly womenDalcroze Eurhythmicsback painleg pain

Outcome Measures

Primary Outcomes (1)

  • Pain levels before exercise program

    Level of pains determined by numeric pain scale 1-10

    From enrollment to the day before the start of the exercise program

Secondary Outcomes (1)

  • Results of pain levels after exercise program

    One month after completion of the exercise program

Study Arms (2)

Intervention group

EXPERIMENTAL

Physical exercises program

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • female, 65+ years old, physical and mental state that allows them to participate in the exercise program (ability to follow the instructions), community dwelling

You may not qualify if:

  • taking analgesics indelibly, Parkinson's or Alzheimer's disease, using social assistance or nursing care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Location

MeSH Terms

Conditions

Back PainHeadache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JANUSZ MACIASZEK, PROF

    Poznan University of Physical Education

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 16, 2024

Study Start

January 11, 2019

Primary Completion

March 8, 2019

Study Completion

July 15, 2019

Last Updated

February 16, 2024

Record last verified: 2024-01

Locations