Exercise and weight loss for hip osteoarthritis: a clinical trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Participants randomised to the intervention group (Better Hip program) will have six individual consultations with a physiotherapist over six months, using the telehealth platform Coviu. The consultations will cover education about osteoarthritis (OA) and discussion of non‐drug treatment options, prescription of an individualised home‐based strengthening program (to be performed independently three times per week) and physical activity plan, behaviour change support, and facilitation of other self‐management strategies. The home‐based strengthening program will comprise 5‐7 strengthening exercises targeting muscle groups around the hip, and will be prescribed to be performed independently at home 3 times a week commencing at the time of the first physiotherapist consultation and continuing for the duration of the 6‐month intervention. Example exercises which may be prescribed as part of the intervention include but are not limited to: prone hip extension against gravity; bridging with progressions including single leg bridging; squats; sit‐to‐stand; step‐ups; seated knee extension; standing/side‐lying hip abduction; crab walks; crook‐lying hip flexion; and standing/side‐lying hip adduction. The intensity for the strengthening exercises will aim for 5‐7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR‐10 scale for strength training. Participants will be instructed that each exercise should be performed slowly and in a controlled manner. Progression will be guided in accordance with American College of Sports Medicine guidelines by adjustments to repetitions, direction, and speed of movements; increasing resistance; and/or changing stance surface. The physical activity plan will comprise a daily step goal that aims to increase on CONDITION: Musculoskeletal ‐ Osteoarthritis Diet and Nutrition ‐ Obesity Hip osteoarthritis;Obesity; ; Hip osteoarthritis ; Obesity Physical Medicine / Rehabilitation ‐ Physiotherapy PRIMARY OUTCOME: Self‐reported severity of hip pain while walking, scored on an 11‐point numeric rating scale (NRS) [Baseline, 6 months (primary timepoint) and 12 months post randomisation; ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of the data set.] Self‐reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub‐scale.[Baseline, 6 months (primary timepoint) and 12 months post randomisation; ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] SECONDARY OUTCOME: Assessment of Quality of Life Instrument (8‐dimension)[Baseline, 6 and 12 months after randomisation ; ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Quality of life subscale of the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)[Baseline, 6 and 12 months after randomisation ; ; ; ; ; ; ; ; ; INCLUSION CRITERIA: Participants will be eligible for the study if they meet the following INCLUSION CRITERIA: i) National Institute for Health and Care Excellence clinical criteria for OA ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Pain subscale of the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)[Baseline, 6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Physical Activity Scale for the Elderly. [Baseline, 6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Proportion of participants using oral pain medications for hip pain. Participants will self‐report the use of any pain medication, defined as one or more of analgesics (paracetamol combinations) and/or oral non‐steroidal anti‐inflammatory drugs and/or oral glucocorticoids and/or oral opioids taken at least once a week in the prior month for their hip pain.[Baseline, 6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Self‐reported hip replacement procedures on study hip[6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Self‐reported willingness to have hip replacement surgery in the near future, scored using a 5‐point Likert scale with anchors “definitely not willing” and “definitely willing”.[Baseline, 6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Function, sports and recreational activities subscale of the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)[Baseline, 6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Global rating of overall change in hip, scored using a 7‐point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline.[6 and 12 months after randomisation i. age 45 years or older; ii. activity‐related hip joint pain; iii. no morning hip stiffness, or morning hip stiffness less than 30 mins ii) report hip pain on most days for 3 months or more; iii) report overall average hip pain in the past week more than or equal to 4 on an 11‐point numerical rating scale (NRS; 0 = no pain, 10 = worst pain possible); ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] Self‐reported weight[Baseline, 6 and 12 months after randomisation ; Tertiary timepoint: participants will also be contacted at two‐years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.] iv) access to a computer/laptop/tablet with internet connection and a webcam for videoconferencing consultations; v) own a smartphone (for pairing with activity tracker); vi) willing and able to participate in video consultations for physiotherapy and dietitian appointments; vii) member of Medibank private with a level of cover that includes arthroplasty surgery; and viii) able to give informed consent and to
Epistemonikos ID: 65ff4d06cafbf0a67bdda8feb30b45cd0e69f810
First added on: Aug 25, 2024