[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Eligibility criteria: age 65 years or older, presence of hip pain 6 months or longer, diagnosed with hip OA and presenting with 1 fall risk factor, a timed up-and-go test (TUG; Podsiadlo & Richardson, 1991) score of 10 s or more, or a history of at least one fall in the past 12 months
Excluded criteria: Exclusion criteria were any joint surgery within the last 6 months, current participation in a group exercise program incorporating balance training or aquatics twice a week or more, and the presence of any medical or neurological condition that significantly affected independence in mobility.
Pretreatment:
Intervention Characteristics
Intervention
Control
Patientrapoprteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelateret livskvalitet
Self-efficacy
Træningsinducerede skader
Smerte (ikke hofterelateret)
Sponsorship source: The Saskatchewan-Canadian Institutes of Health Research Regional Partnerships Program (Sask-CIHR RPP) provided a 2-year fellowship grant for the primary author, and the Physiotherapy Foundation of Canada provided operational funding.
Country: Canada
Setting:
Comments:
Authors name: Arnold, 2010
Institution:
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: – Age between 18 and 85 years– Osteoarthritis (OA) of one or both hip joint(s) (clinical criteria of the American College of Rheumatology)– The subject gives voluntary consent to study participation after receiving oral and written information about study contentand objectives– The subject has the time available to undertake the exercises and attend the measurings– The subject is physically fit for the intervention measure (as ascertained during the examination conducted by the principalinvestigator). “Fitness” in this setting relates to the physical as well as the psychological condition of the subject. (Subjectswill not be excluded if they have one hip endoprosthesis, as long as the contralateral hip is affected by osteoarthritisaccording to the listed criteria.)– The subject has capacity to consent
Excluded criteria: Exclusion criteria– Unstable anchoring of endoprosthetic hip joint– Hip dislocation after endoprosthetic joint replacement– Further disorders affecting the lower extremities or lower back that require treatment by a physician/therapist and which are not connected to the OA and are currently being treated.– The presence of osteoarthritis in several joints (for example, hip and knee) is NOT an exclusion criterion.– Medication or alcohol misuse– Participation in a clinical study in the preceding 4 weeks– Lack of compliance– Acute illness– Use of walking aids– Previous trauma in the hip and pelvis area with accompanying development of secondary osteoarthritis– Known endocrinological causes of hip osteoarthritis– Confirmed metabolic causes of hip osteoarthritis– State after aseptic bone necrosis (Perthes’ disease)– Cardiocirculatory disorders or other comorbidities that result in severely restricted everyday physical capacity and that are contraindications to physical exertion (for example, heart failure NYHA III–IV, terminal renal failure stage IV)– Medical exercise therapy, physiotherapy on resistance machinesin the preceding 3 months, with a total treatment frequency of more than 6 units– Systematic group or individual therapy to treat the osteoarthritis (systematic in the sense of a minimum of 1x/week for 30 minutes or more) in the preceding 3 months– Physical therapy to treat the osteoarthritis (systematic in the sense of regular, prescribed application at least 1x/week) in the preceding 3 months– Newly initiated exercise/movement therapy in the preceding 3 months (sports and movement therapy defined as taking place a minimum of 1x/week, getting out of breath, minimum duration 30 minutes)– Corticosteroid injection into the hip joint in the preceding 12 months.
Pretreatment:
Intervention Characteristics
Intervention
Control
Patientrapoprteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelateret livskvalitet
Self-efficacy
Træningsinducerede skader
Smerte (ikke hofterelateret)
Sponsorship source: The study was supported with training materials by the companies Therabandand Ludwig Artzt.PD Dr Krauß, Dr Steinhilber, Mr Haupt, and Dr Janßen received honoraria forauthorship in the context of the book project “Das Tübinger Hüftkonzept—vonder Wissenschaft in die Praxis” (The Tübingen exercise therapy approach:from science into practice) and have received royalties from hellblau publisher.
Country: Germany
Setting:
Comments:
Authors name: Krauss, 2014
Institution:
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were age 55 years and older, clinical diagnosis of OA of the hip, and living independently.
Excluded criteria: People who were on a waiting list forhip replacement (or who had had a hip replacement in the past year) wereexcluded because an operation could affect their participation in the studyand the program was not developed for a presurgery group. Other exclusioncriteria were: serious disorders or impairments that jeopardized safe use offitness equipment, such as neurological or cardiovascular problems, seriousdepression or dementia (as judged by general practitioners), and regulartreatment by a physical therapist (more than once a week).
Pretreatment: VAS pain at baseline slightly higher in control group than intervention group (4.4 versus 3.8)
Intervention Characteristics
Intervention
Control
Patientrapoprteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelateret livskvalitet
Self-efficacy
Træningsinducerede skader
Smerte (ikke hofterelateret)
Sponsorship source: Supported by a grant from The Netherlands Health Research and Development Council (Preaventiefonds)
Country: The Netherlands
Setting:
Comments:
Authors name: ERWIN TAK, PATRICIA STAATS, ARIËTTE VAN HESPEN, and MARIJKE HOPMAN-ROCK
Institution:
Email:
Address:
Wrong intervention
Wrong patient population
Wrong patient population
Wrong patient population
Wrong intervention
Wrong study design
Wrong intervention
Wrong comparator
Wrong comparator
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Testing was conducted by two experienced physical therapists blinded to group assignment and a research assistant.
Fra SR Fransen et al. 2014
Judgement Comment: Only patient-reported outcomes are used. No mention of blinded analysis
Judgement Comment: Blinded outcomes assessor according to Cochrane review
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: None apparent
Fra SR Fransen et al. 2014
Judgement Comment: What remains unclear is the extent to which our results are generalizable to the treatment of all patients with osteoarthritis of the hip. The sample under study showed moderate disease-related impairments as compared to the average baseline measurements of theWOMAC. In this setting, the SF-36 measurements illustrate that the subjects score higher even than the German normative population sample on the vitality scale and that they have a better perception of their general health. This study is therefore inevitably subject torecruitment bias.
Judgement Comment: None apparent (Fransen, 2014)
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Judgement Comment: Random assignment was conducted by an individual not involved in the research project. Participants were blinded to group assignment until after baseline testing, when they were given a sealed opaque envelope revealing their group assignment.
Fra SR Fransen et al. 2014
Judgement Comment: Allocation concealment was guaranteed by using a sealed opaque envelope that neither the investigators nor the participants were able to view.
Judgement Comment: Not reported (Fransen, 2014)
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Blinding not possible
Fra SR Fransen et al. 2014
Judgement Comment: No blinding of participants and personnel in the intervention group or the passive control. However ultrasound-groups were blinded.
Judgement Comment: Both participants and study personnel were aware of the treatment allocation
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Judgement Comment: 18% and 22% drop outs. Intention-to-treat analysis
Fra SR Fransen et al. 2014
Judgement Comment: 3 versus 8% drop out in the groups. Intention-to-treat analysis performed
Judgement Comment: Drop out 18 % in Intervention group and 9% in control group. However more missing on each outcome. The critical outcome (HHS) has 29% versus 18% without data, hovewer, they perform intention-to-treat analysis.
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: Not reported data on patient reported function (reports only p-value on AIMS-2). No data on pain.
Fra SR Fransen et al. 2014
Judgement Comment: A detailed description of the study protocol has been published (15). The study was registered with the German Clinical Trials Register (DRKS, Deutsches Register für Klinische Studien), No DRKS00000651. Physical outcome testing are stated in the protocol but not mentioned in the present paper, it is assumed to be published separately.
Judgement Comment: None apparent
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: Random assignmentwas conducted by an individual not involved in the research project using acomputer-generated program
Fra SR Fransen et al. 2014
Quote: "Randomization was done stratified by sex. Allocation concealment was guaran- teed by using a sealed opaque envelope that neither the investigators nor the participants were able to view."
Judgement Comment: From protocol paper: the study is divided into four identicalinterventional periods (sequence 1-4), and the mentionedallocation procedure is performed in permutedblocks of 50-60 subjects each. The randomizationsequence is generated electronically prior to each interventionalperiod. Participants draw a lot with a randomizationnumber at the beginning of baselineassessment. This process is double-blinded (participantand investigator).
Judgement Comment: The remaining 109 subjects wererandomly assigned (using computer generated randomized numbers)