OsteoarthritisNCT01164111
Preoperative Resistance Training in Patients Scheduled for Total Hip Arthroplasty
A study testing Preoperative resistance training in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Purpose: The purpose of this study is to determine the effect of pre operative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis. Background: Decreasing performance with age due to age related muscle loss is well known. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Preoperative resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for total hip arthroplasty due to primary osteoarthritis with an age of 50 years or older.
- Patients in the intervention group must participate in 80% of the training as a minimum and more than 2 skipped sessions in a row is not allowed.
Who cannot join
- Rheumatoid arthritis (RA) or other types of arthritis other than primary osteoarthritis.
- Uremia
- Cancer
- Systemic treatment with glucocorticoid more than 3 months the last 5 years with a daily dose > 5 mg.
- Fracture of the hip (ipsi or contralateral)
- Other fracture of the lower extremities the last year
- Other condition with reduced function (ex polio seq.)
- Weight above 135 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Resistance Training in Patients Scheduled for Total Hip Arthroplasty - a Prospective Randomized Study in Patients With Osteoarthritis
Purpose:
The purpose of this study is to determine the effect of pre operative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis.
Read more
Background:
Decreasing performance with age due to age related muscle loss is well known. Resistance training in elderly has shown significant effect in regaining both muscle force and function.
It has been shown that a chronic condition with limitations in function as seen in osteoarthritis of the hip decreases both muscle performance and size.
Studies of resistance training of the hip related muscle groups in the early postoperative period after total hip arthroplasty have shown significant effect on muscle force and function.
Few studies have investigated preoperative intervention, all with lighter types of training such as water pool training.
The effect of preoperative resistance training on subjects with primal osteoarthritis of the hip is yet to be described.
Study hypothesis:
Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre surgery and at 1 year followup.
Read the detailed description
BACKGROUND:
Osteoarthritis of the hip is a common condition among elderly. In Denmark 8000 people underwent operation with total hip arthroplasty in 2007, due to osteoarthritis (Danish Register of hip arthroplasty 2007)).
The number of hip arthroplasties has been doubled the last decade mostly due to an increase in the age group 70-79 years (Danish Register of Hip Arthroplasty 2007). The population of elderly has been increased by to the demographic changes (Danish Statistics). A larger need for treatment could be expected in the future due to this development.
The indications of surgery is pain, reduced function and impaired quality of life related to the hip.
Osteoarthritis is divided into two groups: Primary osteoarthritis and secondary osteoarthritis. The cause of primary osteoarthritis is largely unknown. There is a certain amount of genetic predisposition (Felson et al. 1998), the condition is more common among women and the risk of osteoarthritis is larger with higher body weight (Felson et al. 1988) (Anderson et al. 1988).
Secondary osteoarthritis is seen in rheumatoid arthritis, other types of arthritis and due to morphological conditions in the hip like dysplasia (Jacobsen et al 2005).
Aging is followed by loss of muscle mass -a process accentuated in the late senium (Kyle et al 2001). Loss of muscle mass is related to loss of functions in daily living (Kyle et al 2001)(Jannsen et al 2002).
Conditions with impact on daily living, such as osteoarthritis, is likely to accentuate this process even further. It has been shown that unilateral osteoarthritis of the hip is correlated with a reduction in muscle force, muscle size (cross sectional area) and level of neuromuscular activation (Suetta et al 2007), (Suetta et al 2004).
LOSS OF MUSCLE MASS -AN IMPORTANT FACTOR IN PHYSICAL FUNCTION AND TRAINING IN ELDERLY:
The loss of muscle mass is considered one of the most important factors in loss of function and mobility during aging (Volpi et al 2007).
The loss of lean muscle mass (LLM) is substantial during adult life. In young adults LLM contributes with 50 % to the total body mass (Short et al 2000). Studies have shown a 12-14 % loss of LMM and muscle strength pr decade after the age of 40 (Nair et al 1995), (Roth et al 2000), (Porter et al 1995), (Young et al 1985). At the same time muscle fiber types and fiber composition undergo changes along with changes in the hormonal status - both with effect on tissue regeneration (Lexell et al 1995), (Verdijk et al 2007), (Abbasi et al 1993), (Sattler et al 2009).
RESISTANCE TRAINING IN ELDERLY:
Among healthy elderly resistance training (RT) has significant effect on muscle strength (concentric force - 1 repetition max (1RM), maximum isometric force), physical function and body composition (DEXA scan, ultra sound).
In RT studies the training intensity was typically 80% of 1RM (Sillanpää et al 2008), (Sillanpää et al 2009), (Fiatarone et al 1990), (Fiatarone et al 1994), (Hikida et al 2000) 2-3 times a week, in a period of 8-12 weeks (Vandervoort et al 2003).
RESISTANCE TRAINING AND OSTEOARTHRITIS:
There has only been conducted a few studies concerning progressive resistance training in the period around surgery.
Two clinically controlled trials describe progressive resistance training in the post surgery period and only one study describes the effect of genuine progressive resistance training:
Hesse et al (2003) use treadmill training with partly body weight support after hip arthroplasty. They found significant effects on Harris Hip score and manually rated muscle force. Gait speed remained unchanged.
Suetta et al (2004) (2008) use unilateral progressive resistance training of quadriceps muscle groups in a 12 week program post hip arthroplasty. As shown in healthy elderly they find significant effects on outcome measures like physical performance tests (as stair climb, muscular size (computer tomography scan) and max isokinetic knee extension moment.
RESISTANCE TRAINING PRE-SURGERY VERSUS POST-SURGERY
Only few studies describe different training interventions in the preoperative stage in patients with osteoarthritis (D'Lima et al 1996), (Wang et al 2003), (Gilbey et al 2003), (Rodgers et al 1998), (Gill et al 2009). Most of them describe intervention before total knee arthroplasty.
Only 3 studies designed as randomized clinically controlled studies are conducted pre-surgery on patients scheduled for hip arthroplasty (Wang et al 2003), (Gilbey et al 2003), (Gill et al 2009).
All of those with low intensity training like water pool therapy. To our knowledge no studies have described the effect of progressive resistance training as intervention in the pre operative period.
The findings by Suetta et al (2008) of the effect of progressive resistance training post surgery motivates this study of similar intervention in a pre surgery setting.
PURPOSE:
The purpose of this study is:
- To determine the effect of preoperative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis.
- To determine the effect pre-surgery and post surgery with 1 year follow up.
HYPOTHESIS:
Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre-surgery and at 1 year follow up.
- Conditions
- Osteoarthritis
- Being tested
- Preoperative resistance training
- Keywords
- osteoarthritis, hip arthroplasty, resistance training, preoperative training
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative resistance trainingOther
preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise (stated as 8-10 repetitions of the exercise). Frequency: 2 times/week. The patient follows a special training program consisting of exercises with knee and hip extension. Training intensity is followed in a personalized log-book for each patient. Sessions are conducted in small teams closely supervised by specially trained physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative resistance training | Experimental | preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise. Frequency: 2 times/week Receives: Other: Preoperative resistance training |
| Control | No intervention | Standard preoperative track.: No training intervention. Standard preoperative information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily living)
Questionnaire on Hip Dysfunktion.
Rated questions on:
- symptoms
- stiffness
- pain
- function - daily living
- function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Measured: 0 weeks (entrypoint =T0)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily)
Questionnaire on Hip Dysfunktion.
Rated questions on:
- symptoms
- stiffness
- pain
- function - daily living
- function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Measured: 8 weeks (T1 pre surgery)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Questionnaire on Hip Dysfunktion.
Rated questions on:
- symptoms
- stiffness
- pain
- function - daily living
- function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Measured: 3 months (T3 -post surgery)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Questionnaire on Hip Dysfunktion.
Rated questions on:
- symptoms
- stiffness
- pain
- function - daily living
- function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Measured: 6 months (T4 - postsurgery)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Questionnaire on Hip Dysfunktion.
Rated questions on:
- symptoms
- stiffness
- pain
- function - daily living
- function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative
Measured: 9 months (T5 -post surgery)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Questionnaire on Hip Dysfunktion.
Rated questions on:
- symptoms
- stiffness
- pain
- function - daily living
- function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative
Measured: 12 months (endpoint - post surgery)
Secondary outcomes (28)
Muscle Power
Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.
Measured: 0 weeks (pre surgery)
Muscle strength
Monoarticular measurement of muscle strength. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.
Measured: 0 weeks (pre surgery)
Functional scores
Functional scores:
Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand
Measured: 0 weeks (pre surgery)
Body composition: Dual Energy X-ray Absorptiometry scan(DEXA scan)
DEXA:
Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).
Measured: 0 weeks (pre surgery
Activity score: Metabolic equivalent score (MET- score)
The MET score estimates the metabolic equivalent from an activity questionnaire.
Measured: 0 weeks (pre surgery)
Muscle Power
Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.
Measured: 8 weeks (pre surgery)
Muscle Power
Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.
Measured: 3 months (post surgery)
Muscle Power
Bi-articular measurement of mucle power of leg (knee + hip) extension. Explosive muscle power and power-to-weight ratio of the subject measured by the Nottingham Power rig.
Measured: 12 months (post surgery)
Muscle strength
Monoarticular measurement of muscle strength. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.
Measured: 8 weeks (pre surgery)
Muscle strength
Monoarticular measurement of muscle power. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.
Measured: 3 months (post surgery)
Muscle strength
Monoarticular measurement of muscle strenth. Knee extension and Hip extension respectively. Muscle power measured by isometric force and rate of force development. Measurements on a secured bench specially build for the purpose.
Measured: 12 months (post surgery)
Functional scores
Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand
Measured: 8 weeks (pre surgery)
Functional scores
Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand
Measured: 3 months (post surgery)
Functional scores
Stair climb test: 10 steps up/down. Gait velocity test: 20 meters walk: normal speed, high speed. Chair sit-to-stand
Measured: 12 months (post surgery)
Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)
Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).
Measured: 8 weeks (pre surgery)
Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)
Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).
Measured: 3 months (post surgery)
Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)
Whole body and regional scan to estimate body composition (fat/fat free mass)+ bone density (BMD).
Measured: 12 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
The MET score estimates the metabolic equivalent from an activity questionnaire
Measured: 8 weeks (pre surgery)
Activity score: Metabolic equivalent score (MET score)
The MET score estimates the metabolic equivalent from an activity questionnaire
Measured: 3 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
The MET score estimates the metabolic equivalent from an activity questionnaire
Measured: 6 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
The MET score estimates the metabolic equivalent from an activity questionnaire
Measured: 9 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
The MET score estimates the metabolic equivalent from an activity questionnaire
Measured: 12 months (post surgery)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms)
Questionnaire on Hip Dysfunktion.
Measured: 0 weeks presurgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Questionnaire on Hip Dysfunktion.
Measured: 8 weeks presurgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Questionnaire on Hip Dysfunktion.
Measured: 3 months post surgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Questionnaire on Hip Dysfunktion.
Measured: 6 monts post surgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Questionnaire on Hip Dysfunktion.
Measured: 9 months post surgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Questionnaire on Hip Dysfunktion.
Measured: 12 monts post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Andreas Ebbe Bording Hermann, University of Southern Denmark
- Investigators
- Andreas EB Hermann, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164111
- Sponsor's protocol ID
- H-4-2010-034
- Status last verified
- Oct 2015
- First submitted
- 12 Jul 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dansk Hoftealloplastikregister(register of danish hip arthroplasty). Year report 2007
Danmarks statistik. www.statistikbanken.dk
Felson DT, Couropmitree NN, Chaisson CE, Hannan MT, Zhang Y, McAlindon TE, LaValley M, Levy D, Myers RH. Evidence for a Mendelian gene in a segregation analysis of generalized radiographic osteoarthritis: the Framingham Study. Arthritis Rheum. 1998 Jun;41(6):1064-71. doi: 10.1002/1529-0131(199806)41:63.0.CO;2-K.
PubMed 9627016Felson DT, Anderson JJ, Naimark A, Walker AM, Meenan RF. Obesity and knee osteoarthritis. The Framingham Study. Ann Intern Med. 1988 Jul 1;109(1):18-24. doi: 10.7326/0003-4819-109-1-18.
PubMed 3377350Anderson JJ, Felson DT. Factors associated with osteoarthritis of the knee in the first national Health and Nutrition Examination Survey (HANES I). Evidence for an association with overweight, race, and physical demands of work. Am J Epidemiol. 1988 Jul;128(1):179-89. doi: 10.1093/oxfordjournals.aje.a114939.
PubMed 3381825Jacobsen S, Sonne-Holm S, Soballe K, Gebuhr P, Lund B. Hip dysplasia and osteoarthrosis: a survey of 4151 subjects from the Osteoarthrosis Substudy of the Copenhagen City Heart Study. Acta Orthop. 2005 Apr;76(2):149-58. doi: 10.1080/00016470510030517.
PubMed 16097538Kyle UG, Genton L, Hans D, Karsegard VL, Michel JP, Slosman DO, Pichard C. Total body mass, fat mass, fat-free mass, and skeletal muscle in older people: cross-sectional differences in 60-year-old persons. J Am Geriatr Soc. 2001 Dec;49(12):1633-40. doi: 10.1046/j.1532-5415.2001.t01-1-49272.x.
PubMed 11843996Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PubMed 12028177Suetta C, Aagaard P, Magnusson SP, Andersen LL, Sipila S, Rosted A, Jakobsen AK, Duus B, Kjaer M. Muscle size, neuromuscular activation, and rapid force characteristics in elderly men and women: effects of unilateral long-term disuse due to hip-osteoarthritis. J Appl Physiol (1985). 2007 Mar;102(3):942-8. doi: 10.1152/japplphysiol.00067.2006. Epub 2006 Nov 22.
PubMed 17122381Suetta C, Aagaard P, Rosted A, Jakobsen AK, Duus B, Kjaer M, Magnusson SP. Training-induced changes in muscle CSA, muscle strength, EMG, and rate of force development in elderly subjects after long-term unilateral disuse. J Appl Physiol (1985). 2004 Nov;97(5):1954-61. doi: 10.1152/japplphysiol.01307.2003. Epub 2004 Jul 9.
PubMed 15247162Volpi E, Nazemi R, Fujita S. Muscle tissue changes with aging. Curr Opin Clin Nutr Metab Care. 2004 Jul;7(4):405-10. doi: 10.1097/01.mco.0000134362.76653.b2.
PubMed 15192443Short KR, Nair KS. The effect of age on protein metabolism. Curr Opin Clin Nutr Metab Care. 2000 Jan;3(1):39-44. doi: 10.1097/00075197-200001000-00007.
PubMed 10642082Nair KS. Muscle protein turnover: methodological issues and the effect of aging. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:107-12. doi: 10.1093/gerona/50a.special_issue.107.
PubMed 7493201Roth SM, Ferrell RF, Hurley BF. Strength training for the prevention and treatment of sarcopenia. J Nutr Health Aging. 2000;4(3):143-55.
PubMed 10936901Porter MM, Vandervoort AA, Lexell J. Aging of human muscle: structure, function and adaptability. Scand J Med Sci Sports. 1995 Jun;5(3):129-42. doi: 10.1111/j.1600-0838.1995.tb00026.x.
PubMed 7552755
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Resistance Training in Patients Scheduled for Total Hip Arthroplasty - a Prospective Randomized Study in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT01164111
- Acronym / sponsor ID
- H-4-2010-034
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, hip arthroplasty, resistance training, preoperative training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
The purpose of this study is to determine the effect of pre operative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis.
Background:
Decreasing performance with age due to age related muscle loss is well known. Resistance training in elderly has shown significant effect in regaining both muscle force and function.
It has been shown that a chronic condition with limitations in function as seen in osteoarthritis of the hip decreases both muscle performance and size.
Studies of resistance training of the hip related muscle groups in the early postoperative period after total hip arthroplasty have shown significant effect on muscle force and function.
Few studies have investigated preoperative intervention, all with lighter types of training such as water pool training.
The effect of preoperative resistance training on subjects with primal osteoarthritis of the hip is yet to be described.
Study hypothesis:
Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre surgery and at 1 year followup.
Detailed description
BACKGROUND:
Osteoarthritis of the hip is a common condition among elderly. In Denmark 8000 people underwent operation with total hip arthroplasty in 2007, due to osteoarthritis (Danish Register of hip arthroplasty 2007)).
The number of hip arthroplasties has been doubled the last decade mostly due to an increase in the age group 70-79 years (Danish Register of Hip Arthroplasty 2007). The population of elderly has been increased by to the demographic changes (Danish Statistics). A larger need for treatment could be expected in the future due to this development.
The indications of surgery is pain, reduced function and impaired quality of life related to the hip.
Osteoarthritis is divided into two groups: Primary osteoarthritis and secondary osteoarthritis. The cause of primary osteoarthritis is largely unknown. There is a certain amount of genetic predisposition (Felson et al. 1998), the condition is more common among women and the risk of osteoarthritis is larger with higher body weight (Felson et al. 1988) (Anderson et al. 1988).
Secondary osteoarthritis is seen in rheumatoid arthritis, other types of arthritis and due to morphological conditions in the hip like dysplasia (Jacobsen et al 2005).
Aging is followed by loss of muscle mass -a process accentuated in the late senium (Kyle et al 2001). Loss of muscle mass is related to loss of functions in daily living (Kyle et al 2001)(Jannsen et al 2002).
Conditions with impact on daily living, such as osteoarthritis, is likely to accentuate this process even further. It has been shown that unilateral osteoarthritis of the hip is correlated with a reduction in muscle force, muscle size (cross sectional area) and level of neuromuscular activation (Suetta et al 2007), (Suetta et al 2004).
LOSS OF MUSCLE MASS -AN IMPORTANT FACTOR IN PHYSICAL FUNCTION AND TRAINING IN ELDERLY:
The loss of muscle mass is considered one of the most important factors in loss of function and mobility during aging (Volpi et al 2007).
The loss of lean muscle mass (LLM) is substantial during adult life. In young adults LLM contributes with 50 % to the total body mass (Short et al 2000). Studies have shown a 12-14 % loss of LMM and muscle strength pr decade after the age of 40 (Nair et al 1995), (Roth et al 2000), (Porter et al 1995), (Young et al 1985). At the same time muscle fiber types and fiber composition undergo changes along with changes in the hormonal status - both with effect on tissue regeneration (Lexell et al 1995), (Verdijk et al 2007), (Abbasi et al 1993), (Sattler et al 2009).
RESISTANCE TRAINING IN ELDERLY:
Among healthy elderly resistance training (RT) has significant effect on muscle strength (concentric force - 1 repetition max (1RM), maximum isometric force), physical function and body composition (DEXA scan, ultra sound).
In RT studies the training intensity was typically 80% of 1RM (Sillanpää et al 2008), (Sillanpää et al 2009), (Fiatarone et al 1990), (Fiatarone et al 1994), (Hikida et al 2000) 2-3 times a week, in a period of 8-12 weeks (Vandervoort et al 2003).
RESISTANCE TRAINING AND OSTEOARTHRITIS:
There has only been conducted a few studies concerning progressive resistance training in the period around surgery.
Two clinically controlled trials describe progressive resistance training in the post surgery period and only one study describes the effect of genuine progressive resistance training:
Hesse et al (2003) use treadmill training with partly body weight support after hip arthroplasty. They found significant effects on Harris Hip score and manually rated muscle force. Gait speed remained unchanged.
Suetta et al (2004) (2008) use unilateral progressive resistance training of quadriceps muscle groups in a 12 week program post hip arthroplasty. As shown in healthy elderly they find significant effects on outcome measures like physical performance tests (as stair climb, muscular size (computer tomography scan) and max isokinetic knee extension moment.
RESISTANCE TRAINING PRE-SURGERY VERSUS POST-SURGERY
Only few studies describe different training interventions in the preoperative stage in patients with osteoarthritis (D'Lima et al 1996), (Wang et al 2003), (Gilbey et al 2003), (Rodgers et al 1998), (Gill et al 2009). Most of them describe intervention before total knee arthroplasty.
Only 3 studies designed as randomized clinically controlled studies are conducted pre-surgery on patients scheduled for hip arthroplasty (Wang et al 2003), (Gilbey et al 2003), (Gill et al 2009).
All of those with low intensity training like water pool therapy. To our knowledge no studies have described the effect of progressive resistance training as intervention in the pre operative period.
The findings by Suetta et al (2008) of the effect of progressive resistance training post surgery motivates this study of similar intervention in a pre surgery setting.
PURPOSE:
The purpose of this study is:
- To determine the effect of preoperative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis.
- To determine the effect pre-surgery and post surgery with 1 year follow up.
HYPOTHESIS:
Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre-surgery and at 1 year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative resistance training | Experimental | Other: Preoperative resistance trainingpreoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise. Frequency: 2 times/week |
| Control | No intervention | –Standard preoperative track.: No training intervention. Standard preoperative information. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients scheduled for total hip arthroplasty due to primary osteoarthritis with an age of 50 years or older.
- Patients in the intervention group must participate in 80% of the training as a minimum and more than 2 skipped sessions in a row is not allowed.
Key exclusion criteria (8 listed)
- Rheumatoid arthritis (RA) or other types of arthritis other than primary osteoarthritis.
- Uremia
- Cancer
- Systemic treatment with glucocorticoid more than 3 months the last 5 years with a daily dose > 5 mg.
- Fracture of the hip (ipsi or contralateral)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative resistance trainingpreoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise (stated as 8-10 repetitions of the exercise). Frequency: 2 times/week. The patient follows a special training program consisting of exercises with knee and hip extension. Training intensity is followed in a personalized log-book for each patient. Sessions are conducted in small teams closely supervised by specially trained physiotherapists. | Other | Preoperative resistance training |
Primary outcome
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily living)
Time frame: 0 weeks (entrypoint =T0)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily)
Time frame: 8 weeks (T1 pre surgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Time frame: 3 months (T3 -post surgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Time frame: 6 months (T4 - postsurgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Time frame: 9 months (T5 -post surgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
Time frame: 12 months (endpoint - post surgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative
28 secondary outcomes
Muscle Power
Time frame: 0 weeks (pre surgery)
Muscle strength
Time frame: 0 weeks (pre surgery)
Functional scores
Time frame: 0 weeks (pre surgery)
Body composition: Dual Energy X-ray Absorptiometry scan(DEXA scan)
Time frame: 0 weeks (pre surgery
Activity score: Metabolic equivalent score (MET- score)
Time frame: 0 weeks (pre surgery)
Muscle Power
Time frame: 8 weeks (pre surgery)
Muscle Power
Time frame: 3 months (post surgery)
Muscle Power
Time frame: 12 months (post surgery)
Muscle strength
Time frame: 8 weeks (pre surgery)
Muscle strength
Time frame: 3 months (post surgery)
Muscle strength
Time frame: 12 months (post surgery)
Functional scores
Time frame: 8 weeks (pre surgery)
Functional scores
Time frame: 3 months (post surgery)
Functional scores
Time frame: 12 months (post surgery)
Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)
Time frame: 8 weeks (pre surgery)
Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)
Time frame: 3 months (post surgery)
Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)
Time frame: 12 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
Time frame: 8 weeks (pre surgery)
Activity score: Metabolic equivalent score (MET score)
Time frame: 3 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
Time frame: 6 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
Time frame: 9 months (post surgery)
Activity score: Metabolic equivalent score (MET score)
Time frame: 12 months (post surgery)
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms)
Time frame: 0 weeks presurgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Time frame: 8 weeks presurgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Time frame: 3 months post surgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Time frame: 6 monts post surgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Time frame: 9 months post surgery
Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)
Time frame: 12 monts post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- BackgroundDansk Hoftealloplastikregister(register of danish hip arthroplasty). Year report 2007
- BackgroundDanmarks statistik. www.statistikbanken.dk
- Background: PubMed 9627016Felson DT, Couropmitree NN, Chaisson CE, Hannan MT, Zhang Y, McAlindon TE, LaValley M, Levy D, Myers RH. Evidence for a Mendelian gene in a segregation analysis of generalized radiographic osteoarthritis: the Framingham Study. Arthritis Rheum. 1998 Jun;41(6):1064-71. doi: 10.1002/1529-0131(199806)41:63.0.CO;2-K.
- Background: PubMed 3377350Felson DT, Anderson JJ, Naimark A, Walker AM, Meenan RF. Obesity and knee osteoarthritis. The Framingham Study. Ann Intern Med. 1988 Jul 1;109(1):18-24. doi: 10.7326/0003-4819-109-1-18.
- Background: PubMed 3381825Anderson JJ, Felson DT. Factors associated with osteoarthritis of the knee in the first national Health and Nutrition Examination Survey (HANES I). Evidence for an association with overweight, race, and physical demands of work. Am J Epidemiol. 1988 Jul;128(1):179-89. doi: 10.1093/oxfordjournals.aje.a114939.
- Background: PubMed 16097538Jacobsen S, Sonne-Holm S, Soballe K, Gebuhr P, Lund B. Hip dysplasia and osteoarthrosis: a survey of 4151 subjects from the Osteoarthrosis Substudy of the Copenhagen City Heart Study. Acta Orthop. 2005 Apr;76(2):149-58. doi: 10.1080/00016470510030517.
- Background: PubMed 11843996Kyle UG, Genton L, Hans D, Karsegard VL, Michel JP, Slosman DO, Pichard C. Total body mass, fat mass, fat-free mass, and skeletal muscle in older people: cross-sectional differences in 60-year-old persons. J Am Geriatr Soc. 2001 Dec;49(12):1633-40. doi: 10.1046/j.1532-5415.2001.t01-1-49272.x.
- Background: PubMed 12028177Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
- Background: PubMed 17122381Suetta C, Aagaard P, Magnusson SP, Andersen LL, Sipila S, Rosted A, Jakobsen AK, Duus B, Kjaer M. Muscle size, neuromuscular activation, and rapid force characteristics in elderly men and women: effects of unilateral long-term disuse due to hip-osteoarthritis. J Appl Physiol (1985). 2007 Mar;102(3):942-8. doi: 10.1152/japplphysiol.00067.2006. Epub 2006 Nov 22.
- Background: PubMed 15247162Suetta C, Aagaard P, Rosted A, Jakobsen AK, Duus B, Kjaer M, Magnusson SP. Training-induced changes in muscle CSA, muscle strength, EMG, and rate of force development in elderly subjects after long-term unilateral disuse. J Appl Physiol (1985). 2004 Nov;97(5):1954-61. doi: 10.1152/japplphysiol.01307.2003. Epub 2004 Jul 9.
- Background: PubMed 15192443Volpi E, Nazemi R, Fujita S. Muscle tissue changes with aging. Curr Opin Clin Nutr Metab Care. 2004 Jul;7(4):405-10. doi: 10.1097/01.mco.0000134362.76653.b2.
- Background: PubMed 10642082Short KR, Nair KS. The effect of age on protein metabolism. Curr Opin Clin Nutr Metab Care. 2000 Jan;3(1):39-44. doi: 10.1097/00075197-200001000-00007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas EB Hermann, MD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative resistance training in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily living) (time frame: 0 weeks (entrypoint =T0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01164111, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.