Clinical trial NCT04509427: Exercise and Posture in Individuals with Osteoporosis
Official title: Comparison of Video-based and Paper Instructional Material to Promote EXercise and Posture in Individuals with and Osteoporosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoporosis
Keywords: Exercise Training
Posture training
Web-based video instruction
Handouts
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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 adjunctive therapies to help decrease the risk of fractures and improve the function of individuals with osteoporosis. Often in Rheumatology and osteoporosis clinics, participant's will be given handouts concerning posture and exercise to complete, with little follow-up of their progress or evaluation of their technique. In this study, investigators will determine if the addition a video-based exercise intervention with handouts and limited physical therapist instruction and monitoring help this population increase adoption of a regular exercise program designed to improve lower extremity strength and dynamic posture.

The purpose of this study is to determine if the addition of computer-based video instructions with handouts and limited physical therapist (PT) instruction helps adoption and performance of an intervention designed to improve strength, dynamic posture, and balance in individuals with osteoporosis (OP). Investigators will perform all measurements and interventions via web-based and telecommunication technology. Twenty-four participants will be recruited for this feasibility study using flyers posted in the Rheumatology and Osteoporosis clinics at the University of Alabama at Birmingham (UAB). The investigators, who help staff these clinics, will also alert other clinic physicians of this study via flyers designed for these health care professionals to help recruit study participants. The participants will consent to participate in this study. The UAB Institutional Review Board will approve this study.

After consenting, a physical therapist (PT), blind to group assignment, will perform outcome measurements. Outcome measurements will be assessed at baseline and within a week after the 12-week intervention is completed. Measurements include five-time sit-to-stand-to sit (5xSTS), 4-stage balance test, and a dynamic posture test. Participants will also complete a questionnaire that examines demographics, medical history, exercise and fall perceptions, and functional activity performance. The pre- and post-intervention questionnaires will be similar except the post-intervention questionnaire will not include demographic, medical history questions, and perceived readiness to exercise item. SurveyMonkey will be used to deliver and collect all questionnaire data. The post-intervention questionnaire will contain items assessing intervention satisfaction.

Prior to enrolling participants, investigators will develop a script and checklist for the PT performing the measurements to increase consistency of outcome measurement. The PT will also practice these measurements using Zoom and intra-rater reliability will be determined. Intra-rater reliability will also be assessed from the data collected. Finally, investigators will perform quality control by reviewing recordings of the measurement sessions.

After baseline measurements, participants will be randomly assigned to one of two groups: one group will receive handouts that provide program instructions with PT coaching (HO) or a group who receives the same instructional delivery plus links to web-based videos instructing all elements of the program intervention (HO+). Participants will be asked to perform moderate level exercise/posture activity 5 sessions/week for 35 to 40 minutes per day (duration of activity/session by the end of the intervention). By email, the HO+ group participants will receive handouts with links to access the safe exercise posture instruction, posture warm-up, balance exercise resistance exercise and marching. The HO group will also receive an email that with the same attachments minus the video links. In both groups, the first intervention instruction email will instruct the participants to not start the program until the intervention PT (not the same PT who performs the measurements) guides them through the program via a Zoom videoconference. In week two, the intervention PT will finish the initial instructions in another 60-minute session. The PT will meet with participants during the third week of the intervention for a 15-minute meeting and will continue to meet with participants for 15-minutes every two weeks thereafter via Zoom. During these 15-minute sessions, the intervention PT will help individuals progress exercises, monitor symptoms, answer questions, and make performance recommendations. All participants will be instructed to track their posture and exercise activity by using a monitoring log provided by the research group. These logs will be shared with the investigators.

Both groups 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. Participants will start performing at 5 minutes of marching twice a day. Every two weeks they will progress the goal of marching time by 5 minutes. They will march two times per day until they reach 20 minutes. At this time, they will march one time per day. They will be instructed to march between a rating of 10 -14 on the 20-point Borg scale for rate of perceived exertion. The intervention PT will help participants in both groups progress safely when she teleconferences with each participant every two weeks.

Posture training will be performed daily. The participants will be taught how to hold good posture with activity over two 60-minute sessions by the intervention PT. In the first visit, the intervention PT will discuss holding dynamic posture basics, finding and holding good posture in sitting and sit to stand. In the next visit, she will teach them how to progress to standing activities while holding good posture. The PT will instruct the participant to use the posture activities as a warm-up on all days of exercise. She will also encourage participants to incorporate these skills in daily activities.

The intervention PT will use scripts and checklists developed prior to participant enrollment to ensure consistency of instruction between participants. The intervention PT will practice instructing participants prior to participant enrollment via Zoom with other investigators. These sessions will be taped so that they can be reviewed and scripts and checklists refined.

Demographic, satisfaction data, perception items and scales will be analyzed using appropriate descriptive statistics. Descriptive statistics, such as means and standard deviations, will also be used to describe data from 5xSTS and balance tests. These tests will also be analyzed using Cohen d to determine effect size. To determine within and between group differences over time, mixed-factor ANOVAs will be used. Finally, a Wilcoxon-Signed Rank test will be used to determine differences between the groups for the dynamic posture test.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in 5 times sit to stand from baseline to 3 months
timeFrame: This test will be performed at baseline and within a week after the completion of the intervention
Secondary outcomes:
measure: Change in the 4-stage balance test from baseline to 3 months
timeFrame: This test will be performed at baseline and within a week after the completion of the intervention.
measure: Change of the dynamic posture test for people with osteoporosis from baseline to 3 months
timeFrame: This test will be performed at baseline and within a week after the completion of the intervention
measure: Change in the Self-efficacy for Exercise Scale from baseline to 3 months
timeFrame: This scale will be completed at baseline and within a week after the completion of the intervention
measure: Perceived readiness to exercise item
timeFrame: This item will be completed at baseline only
measure: Change in Falls Efficacy Scale from baseline to 3 months
timeFrame: This scale will be completed at baseline and within a week after the completion of the intervention
measure: Change in Godin Leisure-Time Physical Activity Questionnaire from baseline to 3 months
timeFrame: This scale will be completed at baseline and within a week after the completion of the intervention
measure: Demographic questions
timeFrame: These questions will only be asked at baseline
measure: Intervention satisfaction questions
timeFrame: These questions will only be asked post intervention at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Donald H Lein Jr, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: