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Trial registered on ANZCTR


Registration number
ACTRN12616000506493
Ethics application status
Approved
Date submitted
25/01/2016
Date registered
19/04/2016
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Aerobic Exercise in Sitting Posture versus Aerobic Exercise in Standing Posture in older adults with Knee Osteoarthritis and overweight. Randomized Controlled Trial
Scientific title
Effectiveness of Aerobic Exercise in Sitting Posture versus Aerobic Exercise in Standing Posture in older adults with Knee Osteoarthritis and overweight. Randomized Controlled Trial
Secondary ID [1] 288411 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 297421 0
Overweight and Obesity 297422 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297608 297608 0 0
Physiotherapy
Musculoskeletal 297835 297835 0 0
Osteoarthritis
Diet and Nutrition 297836 297836 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aerobic Exercise in Sitting Position (Experimental Group)

A group of patients suffering Knee Ostearthritis (KOA) will be asked to execute 30 minutes of Aerobic Exercises seated on a chair. The intensity of the exercise is in the range of 50-70% maximal heart rate.
This 30 minutes are organized as follows:
*Five minutes of warm-up: In a seated position: 1 minute of hip flexo-extension to the extent possible. 1 minute of hip flexo-extension while shoulder up and down movements are executed , 1 minute of hip flexo-extension while protraction and retraction of the shoulders are performed, and 1 minute of hip flexo-extension while shoulders rolls are executed. Finally 1 minute of rest.
*Twenty-five minutes of aerobic phase: Patients are asked to execute hip flexo-extension during this 25 minutes without stopping. During this time a sequence of one minute movements with the upper extremity is performed. First exercise of the sequence: 90 degrees of shoulder flexion alternating right and left arms. Second exercise: Touch the knee with the contralateral hand. Third exercise: Clap in front of him with 90 degrees for shoulder flexion. Fourth exercise, patients perform elbow flexo-extension. Fifth exercise of the sequence: consists in hugging himself. This sequence is repeated 5 times.
*Five minutes of cooldown: The same exercises of the warm-up but this time in reverse order.
As with the control group, fifteen minutes of inferior limb strengthening and fifteen minutes of stretching exercises (both regulated by the pain threshold of each subject) will follow this Aerobic Exercise. Strengthening will be executed in a lying position: 10 quadriceps, hamstring, adductors, abductors and sural triceps, isometric contractions, held for 10 seconds with 2 seconds of rest between each repetition, both legs. The stretching will be also performed in a lying position, as follows: 10 Quadriceps, hamstring, adductors, abductors and sural triceps elongations, held for 10 seconds with 2 seconds of rest between each repetition both legs.
This program will be performed 3 times a week during 4 weeks at the “Centro de Especialidades para el Diagnostico y Tratamiento de Azuqueca de Henares” (Specialization of Diagnosis and Treatment Center of Azuqueca de Henares), every session will be led by the 2 investigators both graduated as physiotherapists and working in this project. Once the 12 supervised sessions achieved, a DVD reminder of the routines worked during previous sessions, and produced by the team of investigators will be given to each and every patient in order to enable them to continue the treatment at theirs homes 3 times a week for 8 weeks.
To improve the adherence to the treatment, a self-register format is provided to the patient (a calendar in which the patient will match the days he accomplished the exercise), this paper should be returned to the team every 4 weeks.
Intervention code [1] 293723 0
Rehabilitation
Intervention code [2] 293924 0
Treatment: Other
Comparator / control treatment
Aerobic Exercise in Standing Position (Control group).

A group of patients suffering Knee Ostearthritis (KOA) will be asked to walk in the intervention room (normal walk, without treadmill) for 30 minutes as an Aerobic Exercise. The intensity of the exercise oscillates between 50-70% maximal heart rate.
The 30 minutes of aerobic exercise are organized as follows:
*Five minutes of warm-up: 4 minutes of light walk and 1 minute of rest.
*Twenty-five minutes of aerobic phase: 25 minutes of more vigorous walk (in the range of 50 and 70% maximal heart rate).
*Five minutes of cooldown: 1 minute of rest and 4 minutes of light walk.

Fifteen minutes of inferior limb strengthening and fifteen minutes of stretching exercises (both regulated by the pain threshold of each subject) will follow this Aerobic Exercise. Strengthening will be executed in a lying position: 10 quadriceps, hamstring, adductors, abductors and sural triceps, isometric contractions, held for 10 seconds with 2 seconds of rest between each repetition. The stretching will be also performed in a lying position, as follows: 10 Quadriceps, hamstring, adductors, abductors and sural triceps elongations, held for 10 seconds with 2 seconds of rest between each repetition both legs.
This program will be performed 3 times a week for 4 weeks in the “Centro de Especialidades para Diagnostico y Tratamiento de Azuqueca de Henares” (Specialization of Diagnosis and Treatment Center of Azuqueca de Henares), every session will be guided by the 2 investigators, both graduated as physiotherapist, and working in this project. Once the 12 sessions supervised by the investigators will finish, a DVD reminder of the routines worked during previous sessions will be given to each and every patient in order to enable them to continue the treatment at home 3 times a week during 8 weeks. This digital support is produced by the investigation team.
To improve the adherence to the treatment, a self-register format is provided to the patient (a calendar in which the patient will match the days he accomplished the exercise), this paper should be returned to the team every 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 297149 0
Knee pain assessed using VAS: 100 mm Visual Analogue Scale – validated.
Timepoint [1] 297149 0
Baseline, after 12 sessions (4 weeks), after 24 sessions (8 weeks) and after 36 sessions (12 weeks) of treatment.
Primary outcome [2] 297150 0
Change in Pain, Stiffnes and Physical Function in knee Osteoarthritis is assessed using WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint [2] 297150 0
Baseline, after 12 sessions (4 weeks), after 24 sessions (8 weeks) and after 36 sessions (12 weeks) of treatment
Primary outcome [3] 297151 0
Quality of life is assessed using: SF12: Short Form 12 Health Surveys. 12 items for psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores – Validated.
Timepoint [3] 297151 0
Baseline, after 12 sessions(4 weeks), after 24 sessions (8 weeks) and after 36 sessions (12 weeks) of treatment.
Secondary outcome [1] 320170 0
Treatment adherence is assessed using Adherence percentage and The Therapeutic Exercise Adherence Questionnaire – designed specifically for the study.
Timepoint [1] 320170 0
After 12 sessions (4 weeks) ,24 sessions (8 weeks) and 36 sessions (12 weeks) of treatment.
Secondary outcome [2] 320171 0
Weightloss is assessed by measuring the weigth of each patient in Kg.
Timepoint [2] 320171 0
After 12 sessions (4 weeks) ,24 sessions (8 weeks) and 36 sessions (12 weeks) of treatment.

Eligibility
Key inclusion criteria
Men and women age 50 to 80, with clinical diagnosis of Knee Osteoarthritis by the doctor assigned in the “Centro de Especialidades para el Diagnostico y Tratamiento de Azuqueca de Henares” (Specialisted Center of Diagnosis and Treatment of Azuqueca de Henares) and enrolled with overweight or obese, considering overweight as Body Mass Index (BMI) > 25 kg/m2 and Obesity as (BMI) > 30 Kg/m2.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to walk or exercise without funtional aids, patients with previous knee surgery, and patients with serious unstable medical and psychological condition and patientes with advanced stage of osteoporosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The investigators will prepare 26 sealed opaques envelopes, 13 of them will have the word “seated” and 13 the word “stand” that represent the group to which the subject will be allocated. Once the investigators will selected the subjects eligible for inclusion in the trial, patients will be asked by the external evaluators to choose one sealed opaque envelope, this way, the allocation concealment method will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a randimized controlled trial.

The variable pain was selected as the primary measure in this study.
It has been considered a size effect (ZE) ZE=0.25. The correlation between repeated measurements is assumed at 0.5. Taking in compte that 4 measures has been realized (pre-intervention, post12, post24 and post36 in two treatment groups, the sphericity correction was determined in 0,5.
The statistic power was set up at 0.80, with an alpha level of 0.05, so, a total sample size of 24 patients was estimated. And considering 15% of the losses, it was estimated to reach a total of 26 patients, with 13 subjects per group, using the Gpower Software 3.0.18.

Data will be organised and analysed with the SPSS 22 for Windows.
Two interventions will be compared on an intention to treat basis, irrespective of the degree of compliance with the exercise programme, across 4 measurements, baseline, after 12, 24 and 36 sessions of treatment.
Between group differences will be compared using unpaired T Tests.
Descriptive data will be expressed as mean median and standard deviation.
The significance level will be set
at p=0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
20/04/2016
Date of last participant enrolment
Anticipated
Actual
29/04/2016
Date of last data collection
Anticipated
2/09/2016
Actual
Sample size
Target
26
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 7551 0
Spain
State/province [1] 7551 0
Azuqueca de Henares, Guadalajara

Funding & Sponsors
Funding source category [1] 292759 0
University
Name [1] 292759 0
Universidad de Alcala de Henares
Country [1] 292759 0
Spain
Primary sponsor type
University
Name
Universidad de Alcala de Henares
Address
Campus Universitario - C/ 19, Ctra. Madrid-Barcelona, Km 33,600, 28805 Alcala de Henares, Madrid Espana.
Country
Spain
Secondary sponsor category [1] 291489 0
None
Name [1] 291489 0
Address [1] 291489 0
Country [1] 291489 0
Other collaborator category [1] 278788 0
Hospital
Name [1] 278788 0
Centro de Especialidades para el Diagnostico y Tratamiento de Azuqueca de Henares
Address [1] 278788 0
C/Progreso 1, 19200 Azuqueca de Henares, Espana
Country [1] 278788 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294243 0
Comite de Etica de la Investigacion y de la Experimentacion Animal de la Universidad de Alcala.
Ethics committee address [1] 294243 0
Ctra. Madrid-Barcelona Km 33,600. 28805 – Alcala de Henares Madrid.
Ethics committee country [1] 294243 0
Spain
Date submitted for ethics approval [1] 294243 0
31/07/2015
Approval date [1] 294243 0
13/11/2015
Ethics approval number [1] 294243 0
CEIM/HUM/2015/29
Ethics committee name [2] 294244 0
Comite Etico de Investigacion Clinica del Hospital Universitario Principe de Asturias.
Ethics committee address [2] 294244 0
Carretera Alcala-Meco, s/n, 28805 Alcala de Henares, Madrid
Ethics committee country [2] 294244 0
Spain
Date submitted for ethics approval [2] 294244 0
01/12/2015
Approval date [2] 294244 0
22/12/2015
Ethics approval number [2] 294244 0
OE 28/2015

Summary
Brief summary
The objective of this study is to investigate whether Aerobic Exercises executed in a Sitting Position are more effective than Aerobic ones performed in a Standing Position, both, for treating Knee Osteoarthritis (KOA) on major adults with overweight and obesity.
The greater load applied over the joints, the greater degeneration the joint suffers; and because of the great number of people suffering joints degeneration due to the overweight factor, it is necessary to implement a new therapeutic alternative to adjust to the necessities of this patients. This can be done by making them practice an aerobic training “outload” by employing a chair as a therapeutic tool.
Scientific evidence suggests that the most effective non pharmacological treatment against the KOA is the execution of a program of exercises based on Aerobic Exercise, in combination with strengthening and stretching exercises. For this reason, it is proposed to compare two different kinds of aerobic exercise (standing position (control group, by walking 30 minutes), and sitting position (experimental group, by movements sitting in a chair guided by the investigators for 30 minutes). Immediately both groups will execute the same protocol of 15 minutes of Strengthening exercises (10 isometric quadriceps, hamstring, adductors, abductors and sural triceps contractions held for 10 seconds with 2 seconds of rest between each repetition of both legs), plus 15 minutes of Stretching exercises (quadriceps, hamstring, adductors, abductors and sural triceps stretching held for 10 seconds with 2 seconds of rest between each repetition of both legs). This way, the only difference between groups will be the kind of Aerobic Exercise they will perform.
This program could be divided in two phases:
1. Supervised by the investigators: Participants will attend in groups 3 sessions per week during 4 weeks (12 sessions) to complete this program leaded by the investigators.
2. Individually, each participant will execute the same exercise routine at home, following a DVD provided by the investigators, 3 time a week for 8 weeks (24 sessions).
This way, every intervention group will be evaluated at baseline, after 12, 24 and 36 sessions of treatment with their respective test as follows:
Pain with the Visual Analogue Scale (VAS); Pain, Stiffness and Functional Capacity measured with the Western 'Ontario and McMaster Universities Osteoarthritis Index (WOMAC); the quality’s life evaluated with the Short Form 12 Health Survey (SF12); and the Adherence to the Theurapeutic Exercices tested by the percentage and The Therapeutic Exercise Adherence Questionnary (non validated).
The investigators hypothesize that Aerobic Exercises in a Sitting Position are more effective than in a Standing Position ones to treat patients with KOA and Overweigh or Obesity.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 736 736 0 0
/AnzctrAttachments/369994-Aprobación Comité Universidad.pdf
Attachments [2] 737 737 0 0
/AnzctrAttachments/369994-Dictamen y conformidad OE28-15 HUPA.pdf

Contacts
Principal investigator
Name 63034 0
Miss Betsy Denisse Perez Huerta
Address 63034 0
Universidad de Alcala de Henares - Campus Universitario - Fisioterapia -Ctra. Madrid-Barcelona Km 33,600. 28805 – Alcala de Henares Madrid.
Country 63034 0
Spain
Phone 63034 0
+ 34 69 23 15 150
Fax 63034 0
Email 63034 0
betsy.perez@edu.uah.es
Contact person for public queries
Name 63035 0
Miss Betsy Denisse Perez Huerta
Address 63035 0
Universidad de Alcala de Henares - Campus Universitario - Fisioterapia -Ctra. Madrid-Barcelona Km 33,600. 28805 – Alcala de Henares Madrid
Country 63035 0
Spain
Phone 63035 0
+ 34 69 23 15 150
Fax 63035 0
Email 63035 0
betsy.perez@edu.uah.es
Contact person for scientific queries
Name 63036 0
Miss Betsy Denisse Perez Huerta
Address 63036 0
Universidad de Alcala de Henares - Campus Universitario - Fisioterapia -Ctra. Madrid-Barcelona Km 33,600. 28805 – Alcala de Henares Madrid
Country 63036 0
Spain
Phone 63036 0
+ 34 69 23 15 150
Fax 63036 0
Email 63036 0
betsy.perez@edu.uah.es

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