[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were age less than 70 years, a diagnosis of primary osteoarthritis as the main cause for elective THA surgery, and an ASA score of PI.
Excluded criteria: Exclusion criteria included muscular or skeletal disease that might influence the training and physical testing performance, heart or lung diseases, and diabetes mellitus.
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne, efter endt behandling
Præstationsbaseret funktionsevne, efter endt behandling
Smerte (hofterelateret), efter endt behandling
Helbredsrelateret livskvalitet
Patientrapporteret funktionsevne, langtidseffekt
Hofteluksation, i interventionsperioden
Reoperation, i interventionsperioden
Hævelse, i interventionsperioden
Træningsinducerede skader i bevægeapparatet, i interventionsperioden
Smerte (ikke hofterelateret), i interventionsperioden
Sponsorship source: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.
Country: Norge
Authors name: Husby, 2009
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were: Primary unilateral THR for hip osteoarthrosis (OA), preoperative HOOS ADL67, age>18 years, residence within 30 km from the hospital and willing to participate in training twice a week for 10 weeks.
Excluded criteria: Exclusion criteria were: Resurfacing hip implant,body mass index (BMI)>35, pre-planned supervised rehabilitation, pre-planned contralateral THR within 6 months, inability to speak or read Danish and mental or physical conditions impeding the intervention
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne, efter endt behandling
Patientrapporteret funktionsevne, langtidseffekt
Præstationsbaseret funktionsevne, efter endt behandling
Smerte (hofterelateret), efter endt behandling
Helbredsrelateret livskvalitet, efter endt behandling
Hofteluksation, i interventionsperioden
Reoperation, i interventionsperioden
Hævelse, i interventionsperioden
Træningsinducerede skader i bevægeapparatet, i interventionsperioden
Smerte (ikke hofterelateret), i interventionsperioden
Sponsorship source: The study was supported by grants from The Health Research Fund of Central Denmark Region, The Danish Rheumatism Association (R70-A1104), The Association of Danish Physiotherapists,The Health Foundation and Aase and Ejnar Danielsens Foundation(10-000067). The study sponsors had no role in the study design, collection, analysis and interpretation of data; nor in the writing of the manuscript or the decision to submit the manuscript for publication
Country: Danmark
Authors name: Mikkelsen, 2014
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Eligibility criteria included age of 60 and older and unilateral primary hip replacement due to primary hip osteoarthrosis in patients without card-iopulmonary, neurological, or cognitive problems. To avoid differences in comorbidity between groups, only patients withan American Society of Anesthesiologists (ASA) score of I to II(I=no comorbidity, II=comorbidity but no systemic affection) were included
Excluded criteria: See inclusion
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne, efter endt behandling
Præstationsbaseret funktionsevne, efter endt behandling
Patientrapporteret funktionsevne, langtidseffekt
Smerte (hofterelateret), efter endt behandling
Helbredsrelateret livskvalitet, efter endt behandling
Hofteluksation, i interventionsperioden
Reoperation, i interventionsperioden
Hævelse, i interventionsperioden
Træningsinducerede skader i bevægeapparatet, i interventionsperioden
Smerte (ikke hofterelateret), efter endt behandling
Sponsorship source: None stated
Country: Danmark
Authors name: Suetta, 2004
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Included criteria: Patients diagnosed with primary osteoarthritis, scheduled for elective THA surgery at St Olavs University Hospital, Norway, living within short travel distance to the hospital, were asked to participate in the study
Excluded criteria: Severe osteoarthritis of the contralateral hip, not fully recovered from previous THA surgery, communication difficulties, discharged to a rehabilitation institute, or any illness or disorder that could infl uence the training and/or physical test-ing performance.
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne, efter endt behandling
Præstationsbaseret funktionsevne, efter endt behandling
Smerte (hofterelateret), efter endt behandling
Patientrapporteret funktionsevne, langtidseffekt
Helbredsrelateret livskvalitet, efter endt behandling
Hofteluksation, i interventionsperioden
Reoperation, i interventionsperioden
Hævelse, i interventionsperioden
Træningsinducerede skader i bevægeapperatet, i interventionsperioden
Smerte der ikke er hofterelateret, i interventionsperioden
Sponsorship source: Liaison Committee between the Central Norway Regional Health Authority (RHA) and the Norwegian University of Science and Technology [grant number 2010/708/MOCA]
Country: Norway
Setting: University Hospital
Authors name: Siri B Winther
Institution: Orthopaedic Research Centre, Department of Orthopaedic Surgery, Clinic of Orthopaedics, Rheumatology and Dermatology, St Olavs Hospital HF, Trondheim; 2 Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, Norwegian U.
Email: Siri.bjorgen@ntnu.no
Address: Postbox 8905 MTFS, NO-7491, Trondheim, Norway
Wrong intervention
Wrong intervention
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Wrong intervention
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Wrong intervention
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Wrong study design
Wrong study design
Wrong intervention
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Abstract only
Wrong intervention
Wrong intervention
Wrong intervention
Wrong dose
Wrong intervention
Wrong intervention
Wrong intervention
Wrong study design
Wrong study design
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 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: Not feasible to blind participants.
Judgement Comment: Not feasible to blind participants.
Judgement Comment: Staff was blinded, but blinding participants seems impossible
Judgement Comments: Not possible to blind participants or personnel
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: Reports both data with and without effect. No sign of selective outcome reporting.
Judgement Comment: None detected.
Judgement Comment: No reasons to suspect selective outcome repoting from report however, no pre-specified protocol.
Judgement Comments: Primary outcomes matches protocol. HOOS, 6MWT and NRS however are not reported in protocol (NCT02498093)
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: All participants included in analysis.
Judgement Comment: Small and equal drop out rate i the groups.
Judgement Comment: 25% drop out in control group and 18% in intervention group. No intention-to-treat analysis.
Judgement Comments: Low attrition rates (intervention 4/31, control 2/29 at 3 months)
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: No information
Judgement Comment: None detected.
Judgement Comment: 32 out of 68 refused to participate in trial
SUPPORTING ANNOTATIONS: "Technology [grant number 2010/708/MOCA]. <b>The funding sources had no impact on the analyses, interpretation, or presentation of the data."
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: Not blinded participants. Not described regarding physical performance test.
Judgement Comment: Not blinded participants. Outcome assessores were blinded regarding physical performance test.
Judgement Comment: Not blinded participants. Likely blinded assessors regarding physical performance test.
Judgement Comments: Not reported. Some outcomes are self-reported.
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
SUPPORTING ANNOTATIONS: "We randomly assigned the patients manually by drawing lots. The procedure was performed by 2 persons not familiar with the different treatment options. We"
Judgement Comment: "Sequence in permuted blocks with equal numbers of “intervention” and “control” assignments was obtained".
SUPPORTING ANNOTATION: "The randomization procedure was performed with the aid of a computer program (Minimize version 2.1, C. V.
Jensen, Rigshospitalet; Copenhagen,Denmark), and patients were stratified by age and sex."
SUPPORTING ANNOTATIONS: "The randomization was stratified by sex and concealed by using a web-based service provided by the research department at the university."
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.
SUPPORTING ANNOTATIONS: "We randomly assigned the patients to either the group performing maximal strength train- ing in addition to the conventional rehabilitation program (STG), or to the group that participated in the conventional rehabilitation program only (CRG)."
SUPPORTING ANNOTATIONS: "equal distribution between the groups. <b>Sequence in permuted blocks with equal numbers of “intervention” and “control” assignments was obtained using a simple “shuffling envelope” procedure before study initiation by a secretary not involved in the study.</b> During admission, staff and patients".
Judgement Comment: No infomation.
SUPPORTING ANNOTATIONS: "The randomization was stratifi ed by sex and concealed by using a web-based service provided by the research department at the university."