NCT04630561

Brief Summary

The purpose of this study is to examine the effect of a posture intervention on specific areas of daily function and health: physical, psychological, cognitive, social, and environmental characteristics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

October 28, 2020

Last Update Submit

April 9, 2024

Conditions

Healthy

Keywords

postureexercisecommunity

Outcome Measures

Primary Outcomes (3)

  • Thigh Strength

    Isometric measurement (Newtons) of quadriceps and hamstrings musculature

    12-week differences (Pre- and Post-intervention measures)

  • Posture

    Posture will be measured via the Posture Screen Mobile app. Displacement (mm)

    12-week differences (Pre- and Post-intervention measures)

  • Bone density

    Bone densiometry will be measured via quantitative ultrasound (Achilles EXPII, GE). T-score.

    12-week differences (Pre- and Post-intervention measures)

Secondary Outcomes (10)

  • PROMIS - Physical Activity

    12-week differences (Pre- and Post-intervention measures)

  • PROMIS - Physical Function

    12-week differences (Pre- and Post-intervention measures)

  • PROMIS - Pain Interference

    12-week differences (Pre- and Post-intervention measures)

  • Mindful Attention Awareness Scale (MAAS)

    12-week differences (Pre- and Post-intervention measures)

  • Perceived Stress Scale (PSS-10)

    12-week differences (Pre- and Post-intervention measures)

  • +5 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Subjects will participate in a 15 minute postural intervention program 2-3 times per week

Behavioral: Postural Intervention Program

Control Group

NO INTERVENTION

Subjects will NOT participate in any postural intervention.

Interventions

Postural Intervention ProgramBEHAVIORAL

Dynamic warmup program designed to target several areas of physical and mental wellbeing.

Intervention Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes).
  • Participants also must have a normal (18.5-24.9kg/m2) or overweight BMI (25-29.9kg/m2).
  • Participants must be able to speak, listen, read, and understand sentences written in English.

You may not qualify if:

  • More than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease
  • History of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke)
  • Medications that cause dizziness or slow movement
  • Smoke
  • Body mass to height squared ratio greater than 30kg/m2 or less than 18.4kg/m2, blood pressure greater than 140/90 mmHg, or a history of heart conditions.
  • Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Benjamin Holmes, DC, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 16, 2020

Study Start

November 19, 2020

Primary Completion

March 19, 2024

Study Completion

March 19, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)