[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Inclusion criteria were (1) elective THA (mini mum waiting period of 3wk), (2) OA as underlying diagnosis for THA, (3) age older than 65 years, and (4) a score of 2 or higher on the frailty index Identification of Seniors At Risk (ISAR)
Excluded criteria: Exclusion criteria were (1) unable to understand Dutch, (2) inadequate cognitive functioning (ie, not able to understand instructions), (3) revision of THA, and (4) diagnosed with dementia or severe heart disease.
Pretreatment: More females in the intervention group compared to control (93% versus 97%).Higher (slower) Chair rise time at baseline in intervention group compared to control (47.5 versus 32.7 sec)
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelatered livskvalitet
Træningsinducerede skader
Smerte (ikke hofterelateret)
Sponsorship source: Supported by the Scientific College Physical Therapy of the Royal Dutch Societyfor Physical Therapy
Country: The Netherlands
Setting:
Comments:
Authors name: Oosting, 2012
Institution:
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Patients were eligible if they were aged 45 years, and sufferedfrom a new episode of non-traumatic hip complaints fulfilling theclinical criteria for hip OA of the American College of Rheumatology(ACR)
Excluded criteria: Exclusion criteria:- exercise therapy in the past 3 months;- hip pain score <2 on an 11-point numeric rating scale (NRS:0 ¼ no pain);- high level of physical function (score of <2 on the AlgofunctionalIndex)13,- hip surgery or on waiting list;- disabling co-morbidity (e.g., severe heart failure);- insufficient comprehension of the Dutch language;- mentally incapable of participation
Pretreatment:
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelatered livskvalitet
Træningsinducerede skader
Smerte (ikke hofterelateret)
Sponsorship source: Netherlands Organization for Health Research and Development(Health Care Efficiency Research Program), Dutch Arthritis Foundation, the NetherlandsOrganization for Health Research and Development, Fonds Nuts Ohra, the European Union, Dutch Arthritis Foundatio and personal fees from Biomedis International LTD (Japan).
Country: The Netherlands
Setting:
Comments:
Authors name: Teirlinck, 2016
Institution:
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: Eligible patients were at least 18 years of age and scheduledfor primary unilateral total hip or knee replacement at the SvendborgHospital, Odense University Hospital, Denmark, because of symptomaticOA
Excluded criteria: Exclusion criteria were current or previous fractures in or adjacent tothe joint, inflammatory arthritis and comorbidity diseases, e.g., severe heartdisease and neurological deficits, making exercise and testing impossible.Patients were not included if scheduled for bilateral TJR in the sameprocedure or for geographic reasons, e.g., living on adjacent islands withlogistics making frequent attendance unrealistic
Pretreatment:
Intervention Characteristics
Intervention
Control
Patientrapporteret funktionsevne
Præstationsbaseret funktionsevne
Smerte (hofte)
Helbredsrelateret livskvalitet
Træningsinducerede skader
Smerte (ikke hofterelateret)
Sponsorship source: Tryg Fonden (number7-10-0094). Protesekompagniet, a private Danish corporation supplying orthopedic equipment, funded the exercise machines used for patient assessments. The Parker Institute is supported by grants from the Oak Foundation.A. Villadsen is co-owner of the Danish company Ther-ex (34595208), which produces an exercise application.
Country: Denmark
Setting:
Comments:
Authors name: Villadsen
Institution:
Email:
Address:
Wrong intervention
Wrong comparator
Wrong intervention
Wrong comparator
Wrong study design
Wrong intervention
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 the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
RoB er taget Fra SR Fransen 2014
Fransen et al. 2014
RoB er taget Fra SR Fransen 2014
RoB er taget Fra SR Fransen 2014
Quote: "Randomization took place after stratification by age (65–70y and age 70y), using prepared envelopes per stratum. Within each stratum a permuted block randomization with a block size of 10 was used."
Quote: "For the random allocation sequence (allocation ratio 1:1) a computer-generated random table was used, provided by an in- dependent person. Block randomization was used with random blocks of 4, 6 and 8 patients."
Judgement Comment: Using sequentially numbered, opaque, sealed envelopes produced by a person not otherwise involved in the trial.
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: Low drop out rates
Judgement Comment: Low drop out rates and intention-to-treat analysis performed
Judgement Comment: Low drop out rates + intention-to-treat analysis
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: Concealed by permuted blocks
Quote: "Based on the randomization list, opaque, sealed, sequentially numbered envelopes were prepared by an independent person. In this way the member of the research team was blinded for treatment allocation."
Judgement Comment: Allocation concealed by opaque, sealed envelopes, block randomisation in groups of 4. Instruction to patients concerning not to reveal their group assignment to assessors.
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.
Physiotherapists and participants aware of treatment allocation
Judgement Comment: Not possible
Quote: "Blinding for subsequent treatment of patient, of care provider and researcher during follow-up was not possible due to the intervention of interest."
Judgement Comment: Not possible to blind
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.
n
Blinded outcomes assessor, but participant self reported pain and function
n
n
Judgement Comment: Blinded outcome assessors
Judgement Comment: Only patient-reported outcomes are used
Judgement Comment: Blinded assessment + blinded analysis
n
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
n
Judgement Comment: None apparent, pilot study
Judgement Comment: Pre-registered trial and changes to trial since protocol are described
Judgement Comment: None apparent, pre-registered trial
n
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.
n
Judgement Comment: None apparent
Judgement Comment: None apparent