Exercise and Posture in Individuals with Osteoporosis

NCT04509427 | Withdrawn

• 1 other identifier: EXPO OP TRIAL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoporosis is a common condition found in postmenopausal women. Osteoporosis increases the risk of fractures: especially hip and vertebral fractures. These fractures increase the risk of morbidity and mortality. Falls and movements that incorporate trunk flexion or rotation can increase the risk of fractures in women with osteoporosis. Weight-bearing exercise and posture training are important complementary therapies to help decrease the risk of fractures and improve the function of individuals with osteoporosis. Often in Rheumatology clinic, patient's will be given handouts concerning bone building exercises and tips on holding safe postures with activities to complete, with little follow-up of their progress or evaluation of their technique. In this study, we will compare a video-based exercise intervention with printed handout group to a handout only group and will evaluate the effectiveness of these two different modalities using physical activity measures and overall outcomes of strength and posture.

Conditions

Osteoporosis

Keywords

Exercise Training; Posture training; Web-based video instruction; Handouts

Outcome Measures

Primary Outcomes (1)

• Change in 5 times sit to stand from baseline to 3 months

  5 times sit to stand is a test performed in clinic that assesses lower extremity strength and function. Using a stop watch, an investigator will record the time (in seconds) it takes for an individual to complete five sit-to-stand-to-sit cycles. The participants will cross their arms over their chest and will perform this test using a kitchen or dining room chair placed against the wall.

  This test will be performed at baseline and within a week after the completion of the intervention

Secondary Outcomes (8)

• Change in the 4-stage balance test from baseline to 3 months

  This test will be performed at baseline and within a week after the completion of the intervention.

• Change of the dynamic posture test for people with osteoporosis from baseline to 3 months

  This test will be performed at baseline and within a week after the completion of the intervention

• Change in the Self-efficacy for Exercise Scale from baseline to 3 months

  This scale will be completed at baseline and within a week after the completion of the intervention

• Perceived readiness to exercise item

  This item will be completed at baseline only

• Change in Falls Efficacy Scale from baseline to 3 months

  This scale will be completed at baseline and within a week after the completion of the intervention

Study Arms (2)

Handouts Only (HO) group

ACTIVE COMPARATOR

The HO only group will receive program instructions via handouts and videoconferencing with a physical therapist who will provide intervention instruction, assist with program progression, and monitor participant quality of movement and safety.

Behavioral: Instructional handouts; Behavioral: Physical therapist instruction and monitoring via teleconferencing; Behavioral: Posture training; Behavioral: Marching in place

Handouts plus web-based video (HO+) group

ACTIVE COMPARATOR

The HO+ group will receive the same intervention as the HO group but they will also have access to web-based videos that will lead them through all exercise/posture routines like a commercial exercise video.

Behavioral: Instructional handouts; Behavioral: Physical therapist instruction and monitoring via teleconferencing; Behavioral: Web-based instructional videos; Behavioral: Posture training; Behavioral: Marching in place

Interventions

Instructional handouts BEHAVIORAL

Handouts will include written instructions for each aspect of the multifaceted exercise/posture training program

Handouts Only (HO) group; Handouts plus web-based video (HO+) group

Physical therapist instruction and monitoring via teleconferencing BEHAVIORAL

The intervention physical therapist (PT) meets with them via Zoom for 60 minutes to help them start the program in the first week. This PT will meet with them again in week 2 to complete initial instructions. The PT will meet with them week 3 and then every other week for 15-minutes to help individuals safely progress the program.

Handouts Only (HO) group; Handouts plus web-based video (HO+) group

Web-based instructional videos BEHAVIORAL

Instructional videos that will lead participants through every part of the intervention - like a commercial exercise video.

Handouts plus web-based video (HO+) group

Posture training BEHAVIORAL

Participants will learn how to hold a neutral spine posture during sitting, forward leaning in sitting, sit-to-stand-to-sit, standing, forward leaning in standing, supine-to-sit-to-supine, supine-to-prone-to-supine, and lifting. Principles learned with these functional movement patterns will then be put to practice in common tasks like sweeping, washing dishes, dusting, and gardening. This will be taught over two sessions in the first two weeks of the program. To reinforce holding neutral spine with all activities, participants will perform a 5-minute posture warm-up routine prior to exercising.

Handouts Only (HO) group; Handouts plus web-based video (HO+) group

Marching in place BEHAVIORAL

Participants will perform marching in place five times a week. Participants will be instructed to slowly progress to a goal of performing 30 minutes of marching in place per session. They will be instructed to lift their knees to a height that is between their waist and knee when marching. They will be instructed to march between a rating of 10 -14 on the 20-point Borg scale for rate of perceived exertion

Handouts Only (HO) group; Handouts plus web-based video (HO+) group

Eligibility Criteria

• Age: 51 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal females
• Age \>50
• Confirmed Osteoporosis diagnosis by dual energy X-ray absorptiometryscan
• Ambulatory
• Able to read and speak English
• With access to a computer and/or smartphone to view video material

You may not qualify if:

• Currently meeting the recommended Physical Activity Guidelines for Americans
• Diagnosis of fibromyalgia or other chronic pain syndrome
• Any history of serious cardiac comorbidities or arrhythmias
• Any history of chronic pulmonary condition
• Any history of active cancer
• Any history of active venous thromboemblism
• Any bleeding disorder
• Currently undergoing a PT program or recently completed PT treatment within the last 12 weeks
• Any current orthopedic condition that would preclude patient from exercising regularly
• Any patient scheduled for a future surgical procedure
• Current chronic steroid therapy \>10mg

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Donald H Lein Jr, PT, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The physical therapist responsible for baseline and post-intervention measurements will not know group assignments of the participants. Participants will be told not to tell this physical therapist their group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Continuing Education and Community Outreach

Model Details: After baseline measurements, participants will be assigned to one of two groups. Both groups will receive the same intervention except one group will also receive video instruction of the program intervention. Both groups will receive intervention instruction handouts and video-conferencing with a physical therapist, who will provide initial instruction of the program, assist with program progression, and assess safety and quality of performance of the program by the participants.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: August 12, 2020
• Study Start: December 30, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 19, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12