NCT06820073

Brief Summary

This study aims to evaluate the effects of Global Postural Reeducation (RPG) using the K-Stretch hammock on workers at San Jorge University who experience neck and lower back discomfort due to prolonged sitting. The primary goal is to examine how this intervention impacts posture, musculoskeletal discomfort, flexibility, and range of motion, as well as participants' quality of life, stress levels, and sleep quality. Neck and lower back discomfort are common issues that significantly impact individuals' quality of life and work performance. Global Postural Reeducation (RPG) is a therapeutic approach that focuses on stretching and strengthening muscle chains to improve posture and alleviate discomfort. This study is innovative in applying RPG combined with a specialized K-Stretch hammock to assess its potential benefits in a workplace setting. Participants will include 32 administrative staff members aged 19 to 65 who work predominantly in seated positions and meet specific inclusion criteria. They will undergo a 6-week program involving bi-weekly 30-minute sessions. The study will also compare pre- and post-intervention results to evaluate changes in musculoskeletal discomfort, functional abilities, and physical alignment. Findings from this study may contribute to developing effective workplace interventions for musculoskeletal health.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

January 15, 2025

Last Update Submit

February 5, 2025

Conditions

Keywords

musculoskeletal discomfortLumbar discomfortCervical discomfortGlobal Postural Reeducation (RPG)K-Stretch hammockWorkplace interventionPosture improvementQuality of life enhancement

Outcome Measures

Primary Outcomes (3)

  • Cervical and Lumbar Musculoskeletal Discomfort

    Measured using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ). This tool assesses the severity and frequency of discomfort in cervical and lumbar regions.

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • Cervical and Lumbar Musculoskeletal Discomfort Scale

    Measured using a Numerical Rating Scale (NRS)

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • Improvement in Quality of Life

    Assessed using the EUROQOOL-5D questionnaire, which evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression to determine participants' overall quality of life. The EQ-5D-5L index value ranges from -0.285 (worst possible health state) to 1 (best possible health state), where higher scores indicate a better quality of life. Additionally, the EQ-VAS (EuroQol Visual Analogue Scale) ranges from 0 to 100, with 0 representing "the worst health state imaginable" and 100 representing "the best health state imaginable."

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

Secondary Outcomes (7)

  • Improvement in Functional Capacity of Low Back

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • Improvement in Functional Capacity of Neck

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • Reduction in Perceived Stress

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • Enhancement in Range of Motion

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • Changes in Muscle Tone

    Immediate Intervention Group: Just before the intervention, immediately after (6 weeks), and 6 weeks post-intervention (12 weeks). Delayed Intervention Group: 6 weeks before the intervention, just before, and immediately after the intervention (6 weeks).

  • +2 more secondary outcomes

Study Arms (2)

Immediate Intervention Group: Participants receive the RPG intervention using the K-Stretch hammock

EXPERIMENTAL

Participants in this arm will begin the intervention immediately after enrollment. The intervention involves 12 sessions of Global Postural Reeducation (RPG) using the K-Stretch hammock, delivered over six weeks with two 30-minute sessions per week. These sessions aim to improve posture, reduce cervical and lumbar musculoskeletal discomfort, and enhance flexibility and alignment. Participants will undergo assessments before and after the intervention to measure changes in musculoskeletal discomfort, functional capacity, range of motion, muscle tone, stress levels, and quality of life. This arm serves to evaluate the immediate effects of the RPG intervention, providing data for comparison with the delayed intervention group.

Behavioral: Global Postural Reeducation (RPG) using the K-Stretch hammock

Delayed Intervention Group: Participants receive the RPG intervention after Group 1 completes it.

EXPERIMENTAL

Participants in this arm will receive the Global Postural Reeducation (RPG) intervention using the K-Stretch hammock after Group 1 completes their intervention and post-intervention assessments. The intervention consists of 12 sessions conducted over six weeks, with two 30-minute sessions per week. The sessions are designed to improve posture, reduce cervical and lumbar musculoskeletal discomfort, and enhance flexibility and alignment. Assessments for this group will include a baseline evaluation, conducted prior to the delayed intervention period, and a post-intervention assessment to measure changes in musculoskeletal discomfort, functional capacity, range of motion, muscle tone, stress levels, and quality of life. This arm allows for a comparative analysis of immediate versus delayed intervention outcomes to assess the overall effectiveness of the RPG program.

Behavioral: Global Postural Reeducation (RPG) using the K-Stretch hammock

Interventions

The intervention involves Global Postural Reeducation (RPG) using the K-Stretch hammock. This therapeutic approach focuses on sustained stretching of muscle chains to improve posture, reduce cervical and lumbar musculoskeletal discomfort, and enhance flexibility. Participants complete 12 sessions over six weeks, with two 30-minute sessions per week. Each session includes guided exercises that target muscle imbalances, improve alignment, and alleviate tension caused by prolonged sedentary behavior. The K-Stretch hammock provides support for optimized stretching and alignment during the exercises.

Delayed Intervention Group: Participants receive the RPG intervention after Group 1 completes it.Immediate Intervention Group: Participants receive the RPG intervention using the K-Stretch hammock

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a university administrative or technical staff member over 18 years old who works in a seated position during the workday.
  • Have at least one year of experience in the current position.
  • Present nonspecific cervical and/or lumbar musculoskeletal discomfort.

You may not qualify if:

  • Be pregnant or breastfeeding.
  • Have a diagnosed condition that prevents participation in an RPG session using the K-Stretch hammock.
  • Participate in activities involving RPG and/or back health programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Zaragoza, Zaragoza, 50830, Spain

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study is open-label, and no masking is applied. Both participants and investigators are aware of the group assignments and the intervention being conducted. However, data analysis is performed on pseudonymized datasets to maintain objectivity and confidentiality. The individual responsible for assigning participant codes is not involved in data analysis, ensuring that any potential bias is minimized during the statistical evaluation process.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study employs an interventional, two-group, randomized, controlled design to evaluate the effects of Global Postural Reeducation (RPG) using the K-Stretch hammock on musculoskeletal discomfort and related outcomes. Participants are randomly assigned to either Group 1, which undergoes the intervention in the first six weeks, or Group 2, which receives the same intervention after Group 1 completes its post-intervention assessment. Each group participates in 12 sessions, lasting 30 minutes each, conducted twice weekly. The intervention involves targeted stretching techniques focused on improving posture, reducing musculoskeletal discomfort, and enhancing flexibility and alignment. Assessments are conducted at baseline, after Group 1 intervention, and after Group 2 intervention to compare pre- and post-intervention outcomes and ensure a robust evaluation of the intervention's effectiveness.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2025

First Posted

February 11, 2025

Study Start

February 1, 2025

Primary Completion

April 20, 2025

Study Completion

October 1, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations