Technology Supported High Intensity Training at Home for Persons With Chronic Low Back Pain: a Pilot Study.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Intrinsic motivation inventory (IMI)
研究概览
简要总结
1. Background 1.1 Introduction Chronic low back pain (CLBP) is the most disabling musculoskeletal disorder worldwide4. Exercise therapy can improve CLBP, but effect sizes remain modest. Recently, our research group has shown that high intensity training (HIT) is a feasible and effective therapy modality to significantly improve physical fitness and reduce functional disability in comparison to moderate intensity training in persons with moderately disabling CLBP9. However, persons with CLBP often do not continue exercising after discharge, which can lead to a decline of (long term) treatment effects. A technology supported home program, that guides the substantial effort that is necessary for further improvement, may enhance (the retention of) training effects.
1.2 Objective, research questions, and hypotheses
Primary objective:
To evaluate the feasibility of a technology supported HIT program performed at home in persons with CLBP.
Secondary objective:
To assess the clinical effectiveness of a technology supported HIT program performed at home in persons with CLBP.
Research questions and hypotheses:
Research question (RQ)1 - To which extent is it feasible to perform HIT at home in persons with CLBP? Hypothesis (HP)1 - A high intensity training program performed at home by persons with CLBP is feasible, conceptualized by retained or improved participant motivation, high therapy adherence, and absence of adverse events.
RQ2 - To which extent is it feasible to use Physitrack as a supportive technology application during HIT at home in persons with CLBP? HP2 - It is feasible to use Physitrack to support persons with CLBP that perform a HIT program at home (i.e. provide information concerning the exercise program and provide feedback), conceptualized by an evaluation of the Physitrack application on the usability score of 'above average'.
RQ3 - To which extent is a technology supported HIT program an effective therapy modality to treat persons with CLBP? HP3: A technology supported HIT program is an effective therapy modality to treat persons with CLBP, conceptualized by a significant increase in physical fitness, and decrease in pain intensity and functional disability.
详细描述
2. Material and methods 2.1 Study design This pilot cohort study includes one group of 15 participants (i.e. persons with CLBP) and involves a six-week HIT exercise intervention with a total of 12 rehabilitation sessions (two sessions per week). Four initial sessions are performed at REVAL Research Center, UHasselt to educate participants on how to perform the exercise protocol. Eight successive exercise sessions are performed in the home setting of each participant with the support of the Physitrack technology (a mobile application for participants and a software platform for researchers). Participants perform an assessment at baseline (PRE, physical testing and questionnaires), after two weeks of in-center rehabilitation (MID, questionnaires online only), and at the end of the home sessions (POST, physical testing and questionnaires). PRE and POST measurements are carried out in REVAL, UHasselt. MID measurements are carried out online through the use of an online survey (Qualtrics software). An overview of the study design can be found in Figure 1.
Figure 1: study design. 2.2 Participants
Inclusion criteria:
Persons with CLBP will be recruited regionally (Limburg, Belgium) through local advertisements and social media (via a flyer, see appendix).
To be included, persons have to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •speak Dutch
- •have CLBP of a nonspecific origin (i.e. medical diagnosis of pain localized below the costal margin and above the inferior gluteal folds with or without referred leg pain of a nociceptive mechanical nature, not attributable to a recognizable, known specific pathology, for example, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome for a period of at least 12 weeks1). All patients will be asked to provide proof of this medical diagnosis via a GP or specialist referral letter.
- •You have an Android or iOS smartphone
排除标准
- •have a history of spinal fusion
- •suffer of any cardiac disease
- •have an acute or chronic musculoskeletal disorder aside from CNSLBP that could affect the correct execution of the therapy program
- •have comorbidities (e.g., paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis)
- •are pregnant or try to be
- •have ongoing compensation claims and/or a work disability >6 months
- •have followed an exercise therapy program for low back pain in the past 3 months
- •are not able to attend regular therapy appointments.
结局指标
主要结局
Intrinsic motivation inventory (IMI)
时间窗: POST (after finalizing the 6-week protocol)
This is a nominal 35 item questionnaire that assesses the multidimensional subjective experience while performing a certain activity (i.e. the high intensity training protocol) yielding six subscales (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice), with the possibility of independent scoring for each scale and a general scoring. A higher score correlates to higher intrinsic motivation (total range 35-245).
Motivation Visual Analog Scale (MVAS) and Satisfaction Visual Analog Scale (SVAS)
时间窗: POST (after finalizing the 6-week protocol)
This nominal scales is used to evaluate satisfaction with rehabilitation and consist of a line indicating eleven successive scores (0-10), whereby zero means 'no satisfaction' and ten means 'very high satisfaction'.
System Usability Scale (SUS)
时间窗: POST (after finalizing the 6-week protocol)
Participants will complete this questionnaire to assess perceived usability of Physitrack. The SUS is a standard 10-item questionnaire in which responses are measured on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 1, 3, 5, 7, and 9 are positive and questions 2, 4, 6, 8, and 10 are negative. A total SUS score is derived by summing the individual scores and multiplying by 2.5, which yields a score ranging between 0 (worst) and 100 (absolute best). A score \>68 is considered above average usability and \>80 considered high usability and a level at which participants are likely to recommend the product to peers.
Satisfaction Visual Analog Scale (SVAS)
时间窗: PRE (baseline)
This nominal scales is used to evaluate satisfaction with rehabilitation and consist of a line indicating eleven successive scores (0-10), whereby zero means 'no satisfaction' and ten means 'very high satisfaction'.
Motivation Visual Analog Scale (MVAS)
时间窗: POST (after finalizing the 6-week protocol)
This nominal scales is used to evaluate motivation for rehabilitation and consist of a line indicating eleven successive scores (0-10), whereby zero means 'no motivation' and ten means 'very high motivation'.
次要结局
- Brief Pain Inventory short form (BPI-sf)(POST (after finalizing the 6-week protocol))
- Modified Oswestry Disability Index (MODI)(POST (after finalizing the 6-week protocol))
- Fear-Avoidance Components Scale (FACS)(POST (after finalizing the 6-week protocol))
- Therapy adherence(POST (after finalizing the 6-week protocol))
- Adverse events(POST (after finalizing the 6-week protocol))
- Maximum exercise test(POST (after finalizing the 6-week protocol))
- International Physical Activity Questionnaire short form (IPAQ)(POST (after finalizing the 6-week protocol))
研究者
Annick Timmermans
Associate Professor
Hasselt University