NCT03831737

Brief Summary

This research is being done to explore the potential benefit of a physical therapist-guided stretching program on musculoskeletal pain and well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

February 4, 2019

Last Update Submit

December 20, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • SF-36

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.

    change from 3 month time point to 6 month time point

  • CMDQ

    The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) is a questionnaire based on previous published research studies of musculoskeletal discomfort among office workers.

    change from 3 month time point to 6 month time point

Secondary Outcomes (3)

  • Modified Sit and Reach

    baseline, 3 months, 6 months, change from 3 month time point to 6 month time point

  • SF-36

    baseline, 3 months

  • CMDQ

    baseline, 3 months

Study Arms (2)

Group 1: In-Person

EXPERIMENTAL

During the initial 3 month control period, subjects are asked not to begin any new exercise or stretching program during this time. During the 3 month intervention period that follows, subjects will participate in in-person physical therapist-led instructional sessions three times per week. Each stretch will be performed twice, one on the left and one on the right. The therapist will describe what to do and briefly demonstrate each stretch. Stretches will be held for 45-60 seconds with therapist instructions and modification as needed based on subject technique.

Behavioral: stretching exercises

Group 2: Video

EXPERIMENTAL

During the initial 3 month control period, subjects are asked not to begin any new exercise or stretching program during this time. During the 3 month intervention period that follows, subjects will complete sessions three times per week, led by a physical therapist and viewed remotely via pre-recorded video using a smartphone application.

Behavioral: stretching exercises

Interventions

Head/neck stretches * Head tilt side to side * Cross-chest stretch Torso stretches * Side stretch * Mid-back stretch Lower limb * Standing quadriceps stretch * Standing hamstring stretch

Group 1: In-PersonGroup 2: Video

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HMC/COM staff (faculty, residents, fellows, APPs, physical/occupational therapists, nurses, schedulers, etc.)
  • At least 18 years old
  • Willing and able to participate in all study procedures
  • Willing and able to provide informed consent
  • Group 2 subjects must have access to a computer with internet or an iPhone or Android smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aiesha Ahmed, MD

    Penn State Health Milton S Hershey Medical Center

    PRINCIPAL INVESTIGATOR
  • Majid Dadgar-Kiani, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Neuromuscular Neurology

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 6, 2019

Study Start

February 11, 2019

Primary Completion

September 10, 2019

Study Completion

September 10, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations