Comparison of Video-based and Paper Instructional Material to Promote EXercise and Posture in Individuals with and Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in 5 times sit to stand from baseline to 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females
- •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
排除标准
- •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
结局指标
主要结局
Change in 5 times sit to stand from baseline to 3 months
时间窗: This test will be performed at baseline and within a week after the completion of the intervention
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.
次要结局
- Perceived readiness to exercise item(This item will be completed at baseline only)
- Intervention satisfaction questions(These questions will only be asked post intervention at 3 months)
- 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)
- 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)
- Change in Godin Leisure-Time Physical Activity Questionnaire from baseline to 3 months(This scale will be completed at baseline and within a week after the completion of the intervention)
- 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.)
- Demographic questions(These questions will only be asked at baseline)
研究者
Donald Lein
Associate Professor, Director of Continuing Education and Community Outreach
University of Alabama at Birmingham