NCT07596602

Brief Summary

Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. However, existing literature primarily focuses on younger populations using mat-based group classes. This pilot study utilizes an exploratory mixed-methods design to investigate the feasibility and preliminary outcomes of a 12-week individualized, machine-based Classical Pilates program on quality of life and low back pain in active older adults (aged 55 to 75 years). Participants will complete 24 individual sessions (twice a week). The aim is to assess changes in physical domains of quality of life and perceived low back pain intensity, while gathering qualitative contextual insights on body awareness and psychosocial well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable low-back-pain

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

October 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Quality of LifeLow Back PainPilatesActive AgingIndividualized Training,

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life

    Assessed using the World Health Organization Quality of Life Brief (WHOQOL-Bref) questionnaire. It evaluates four domains: physical, psychological, social relationships, and environment. Responses are recorded on a five-point scale, where higher scores indicate a better perceived quality of life.

    Baseline (Week 0) and Post-Intervention (Week 13).

Study Arms (1)

Machine-Based Pilates Group

EXPERIMENTAL

A 12-week program consisting of two individual 50-minute sessions per week. The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment). The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks). Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.

Behavioral: Machine-Based Classical Pilates Program

Interventions

A 12-week program consisting of two individual 50-minute sessions per week. The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment). The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks). Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.

Machine-Based Pilates Group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 55 and 75 years.
  • Physically active in daily routines.
  • No previous experience with machine-based Pilates.
  • Presenting with moderate disability (Oswestry Disability Index = 21% to 40%) caused by low back pain.

You may not qualify if:

  • Absolute contraindications to physical exercise.
  • Severe spinal pathologies (e.g., hernias requiring surgery, severe osteoporosis, idiopathic scoliosis).
  • Previous or scheduled spinal surgeries.
  • Severe disability (Oswestry Disability Index \> 41%).
  • Chronic obstructive pulmonary disease.
  • Recent stroke or myocardial infarction.
  • Uncontrolled hypertension.
  • Active oncological treatment.
  • Physical therapy treatment for low back pain within the six months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Politécnico de Leiria

Leiria, Leiria District, 2411-901, Portugal

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All eligible participants are assigned to a single experimental arm to receive the 12-week machine-based Pilates intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

October 21, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Data will be available on request from the corresponding author due to privacy and ethical restrictions.

Shared Documents
STUDY PROTOCOL

Locations