Technology Supported High Intensity Training at Home for Persons With Chronic Low Back Pain

NCT05234008 | Unknown Phase 3

• 1 other identifier: B1152021000020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain; Exercise Therapy; Telerehabilitation

Outcome Measures

Primary Outcomes (10)

• Motivation Visual Analog Scale (MVAS)

  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'.

  PRE (baseline)

• Motivation Visual Analog Scale (MVAS)

  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'.

  MID (after 2 weeks of intervention)

• Motivation Visual Analog Scale (MVAS)

  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'.

  POST (after finalizing the 6-week protocol)

• Satisfaction Visual Analog Scale (SVAS)

  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'.

  PRE (baseline)

• Motivation Visual Analog Scale (MVAS) and Satisfaction Visual Analog Scale (SVAS)

  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'.

  MID (after 2 weeks of intervention)

• Motivation Visual Analog Scale (MVAS) and Satisfaction Visual Analog Scale (SVAS)

  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'.

  POST (after finalizing the 6-week protocol)

• Intrinsic motivation inventory (IMI)

  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).

  PRE (baseline)

• Intrinsic motivation inventory (IMI)

  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).

  MID (after 2 weeks of intervention)

• Intrinsic motivation inventory (IMI)

  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).

  POST (after finalizing the 6-week protocol)

• System Usability Scale (SUS)

  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.

  POST (after finalizing the 6-week protocol)

Secondary Outcomes (16)

• Brief Pain Inventory short form (BPI-sf)

  PRE (baseline)

• Brief Pain Inventory short form (BPI-sf)

  MID (after 2 weeks of intervention)

• Brief Pain Inventory short form (BPI-sf)

  POST (after finalizing the 6-week protocol)

• Modified Oswestry Disability Index (MODI)

  PRE (baseline)

• Modified Oswestry Disability Index (MODI)

  MID (after 2 weeks of intervention)

Study Arms (1)

home therapy group

EXPERIMENTAL

one group of 15 participants (i.e. persons with CLBP) performing a six-week HIT exercise intervention with a total of 12 rehabilitation sessions (two sessions per week).

Other: High intensity training at home

Interventions

High intensity training at home OTHER

A HIT exercise intervention is performed. Four sessions are performed at REVAL Research Center to educate participants on the exercise protocol. Eight exercise sessions are performed at home with support of Physitrack (a mobile application for participants and a software platform for researchers). In-center program (2 weeks, 4 sessions): Participants perform a concurrent exercise protocol of 1h-1.5h, as published by our research team previously, consisting of cardiorespiratory, general resistance, and core muscle training, all at high intensity. Home sessions (4 weeks, 8 sessions): Researchers provide participants with a fitness bike, smartwatch, and training mat. Using Physitrack, researchers formulate a personalized HIT program to be performed at home for each participant by selecting from \>3500 exercises or insert a new exercise to add to the library. This HIT program resembles the program performed in the rehabilitation center as much as possible.

home therapy group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

Study Officials

• Annick Timmermans, PhD

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Verbrugghe, PhD

CONTACT

+3211269224; jonas.verbrugghe@uhasselt.be

Marleen Missotten

CONTACT

cme@uhasselt.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 10, 2022
• Study Start: February 15, 2022
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)