Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain

NCT ID: NCT06886906

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2026-08-01

Brief Summary

The purpose of this research study is to evaluate the effect of brief bouts of intermittent walking on bodily pain, pain during movement, and how the body adapts to musculoskeletal pain in older adults.

Detailed Description

The purpose of this study is to determine whether exposure to acute sitting compared to sitting interrupted with brief bouts of light intensity walking exerts short term effects on resting pain, endogenous pain modulation measured via quantitative sensory testing (QST), and movement-evoked pain (MEP) in older adults. Participants will be asked to complete two study sessions, with the first study session lasting 3 hours and the second study session lasting 2.5 hours. All sessions will take place in the National Institute of Sport Fitness, where the Physical Activity and Pain laboratory is located. The first session will include the following procedures in the following order: informed consent process, healthy history for screening purposes, quantitative sensory testing (QST), 6-minute walk test, completion of questionnaires, QST, experimental conditions of either 1 hour of sitting or 1 hour of sitting with bouts of light intensity walking, QST, and the 30-second chair stand test. Session 2 will take place at least 7 days after session 1 and will be identical except for the informed consent and screening will be replaced by questionnaires and the experimental condition will consist of the one not performed in session 1. Participants will be asked to take their medications at the same time prior to each study visit and we will assess medications taken the day of each visit prior to the visit.

Conditions

Older People; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Uninterrupted Sitting for 1 hour

The participant will remain seated throughout the experimental period and will be instructed to minimize excessive movement, only rising from the chair to void. This experimental condition is designed to mimic prolonged uninterrupted sedentary behavior.

Group Type: EXPERIMENTAL

uninterrupted sitting

Intervention Type: BEHAVIORAL

The participant will remain seated throughout the experimental period and will be instructed to minimize excessive movement, only rising from the chair to void. This experimental condition is designed to mimic prolonged uninterrupted sedentary behavior.

1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking

Participants will sit as described above with six bouts of 2.5-minutes of light intensity walking (see Figure 2). Overall, the bouts will occur on six occasions, providing a total of 15 minutes of light intensity activity. Participants will be asked to walk at a light intensity based on the 6-20 RPE scale, which corresponds to a 9-11 RPE rating. This experimental condition is designed to mimic sedentary behavior interspersed with frequent short bouts of LPA. RPE and pain intensity (0-100 scale) will be assessed at the end of each walking bout.

Group Type: EXPERIMENTAL

Intermittent light walking

Intervention Type: BEHAVIORAL

The participant will remain seated throughout the 1 hour experimental period. During this 1-hour period, participants will complete six bouts of 2.5-minutes of light intensity walking. Overall, the bouts will occur on six occasions, providing a total of 15 minutes of light intensity activity.

Interventions

Intermittent light walking

The participant will remain seated throughout the 1 hour experimental period. During this 1-hour period, participants will complete six bouts of 2.5-minutes of light intensity walking. Overall, the bouts will occur on six occasions, providing a total of 15 minutes of light intensity activity.

Intervention Type: BEHAVIORAL

uninterrupted sitting

The participant will remain seated throughout the experimental period and will be instructed to minimize excessive movement, only rising from the chair to void. This experimental condition is designed to mimic prolonged uninterrupted sedentary behavior.

Intervention Type: BEHAVIORAL

Other Intervention Names

1 hour of sitting interrupted with 2.5 minute bouts of light intensity walking

Eligibility Criteria

Inclusion Criteria

• Community-dwelling men and women
• Answer yes to the following question: Have you experienced any musculoskeletal pain (pain affecting joints, bones, ligaments, tendons or muscles) in the past month?

Exclusion Criteria

• Cardiovascular issues such as uncontrolled blood pressure over 150/99 mmHg, heart failure, or history of acute myocardial infarction;
• Angina in the last month (squeezing, pressure, heaviness, tightness, or pain in chest)
• Serious systemic disease or condition (e.g., severe osteoarthritis, injury) that restricts normal daily activities
• Neurological disease (e.g., Parkinson's Disease, multiple sclerosis, epilepsy)
• Serious psychiatric conditions (schizophrenia, bipolar disorder) or hospitalization within the preceding year for psychiatric illness
• Known peripheral neuropathy
• Chronic opioid use (defined as ≥ 90 days)
• Unable to walk for 6 minutes without assistive devices

• Participants will be asked to not participate in vigorous or unaccustomed exercise 48 hours prior to each study session.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kelly Naugle, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly Marie Naugle

Role: PRINCIPAL_INVESTIGATOR

School of Health and Human Sciences, IUPUI

Locations

250 University Blvd

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelly M Naugle, PhD

Role: CONTACT

kmnaugle@iu.edu

+3172740601

Facility Contacts

Kelly M Naugle, PhD

Role: primary

kmnaugle@iu.edu

317-274-0601

Other Identifiers

24426

Identifier Type: -

Identifier Source: org_study_id