Rehabilitation Strategies for Elderly Post-Operative PatientsNCT00559780
Muscle Function in Elderly Postoperative Patients
A study testing Resistance training, Neuromuscular electrical stimulation of the quadriceps muscle and Standard rehabilitation in people with Rehabilitation Strategies for Elderly Post-Operative Patients, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
During the last decades there has been an increase in the relative proportion and life expectancy of elderly people in the industrialised countries. Consequently the amount of elderly with diseases and disabilities related to aging has increased. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rehabilitation Strategies for Elderly Post-Operative Patients
- What is being tested?
- Resistance training, Neuromuscular electrical stimulation of the quadriceps muscle and Standard rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- May 2000to Dec 2003
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 60 years
- Unilateral primary hip replacement due to hip osteoarthritis in patients
Who cannot join
- Cardiopulmonary, neurological or cognitive problems
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine, Bispebjerg Hospital
Copenhagen, 2400-NV
About this study
Official title: Muscle Function in the Elderly After Hip-Replacement Surgery - Effects of Long Term Disuse and Physical Training
During the last decades there has been an increase in the relative proportion and life expectancy of elderly people in the industrialised countries. Consequently the amount of elderly with diseases and disabilities related to aging has increased. It therefore appears paramount to gain a better understanding of how disuse and immobilisation affects neuromuscular properties in the elderly, as well as to identify training regimes that ensures an effective rehabilitation.The population of interest in the present study was elderly individuals with long term hip-osteoarthritis undergoing a hip-replacement operation. The study was divided in two parts, a cross-sectional study and an intervention study.
The cross-sectional study investigated muscle size, maximal muscle strength, specific force, neural drive and explosive muscle force characteristics in elderly individuals who were affected by unilateral prolonged disuse due to hip-osteoarthritis. The data clearly indicated that the side with hip-osteoarthritis was affected by a marked decrease in muscle mass, maximal muscle strength, neural drive and explosive muscle force characteristics compared to the unaffected side.
The intervention study investigated if elderly patients that undergo hip-replacement surgery could benefit from additional training in the early postoperative phase. The data clearly demonstrated that resistance training was an effective and safe way to increase muscle mass, maximal muscle strength, neuromuscular activity, functional performance and decrease the hospitalisation period compared to regimes of conventional rehabilitation regimen or electrical muscle stimulation. Additionally the intervention study demonstrated that resistance training effectively induced marked increases in explosive muscle force characteristics in elderly subjects compared to rehabilitation regimes using electrical muscle stimulation or conventional rehabilitation. Furthermore, the gains in maximal muscle strength and explosive muscle force characteristics were accompanied by significant increases in EMG amplitudes. Furthermore, the demonstration that explosive muscle force capacity of the neuromuscular system remains trainable in elderly recovering from prolonged limb disuse and major surgery may have important implications for future rehabilitation programs, especially when considering the importance of rapid muscle force capacity on postural balance, maximal walking speed and other tasks of daily life actions.
- Being tested
- Resistance training, Neuromuscular electrical stimulation of the quadriceps muscle, Standard rehabilitation
- Keywords
- Resistance training, Aging, hip-surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
12 weeks of resistance training (3/week)
Neuromuscular electrical stimulation of the quadriceps muscleBehavioural
12 weeks of neuromuscular electrical stimulation of the quadriceps muscle (1h/day)
Standard rehabilitationBehavioural
12 weeks of standard physiotherapy exercises (1h/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12 weeks of resistance training Receives: Behavioral: Resistance training |
| 2 | Experimental | 12 weeks of neuromuscular electrical stimulation Receives: Behavioral: Neuromuscular electrical stimulation of the quadriceps muscle |
| 3 | Other | 12 weeks of standard rehabilitation Receives: Behavioral: Standard rehabilitation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startMay 2000
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation Strategies for Elderly Post-Operative PatientsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte Suetta, MD, PhD, Principal investigator, Institute of Sports Medicine copenhagen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559780
- Sponsor's protocol ID
- HKF:01058/00
- Other IDs
- HKF:01058/00
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Function in the Elderly After Hip-Replacement Surgery - Effects of Long Term Disuse and Physical Training
- ClinicalTrials.gov ID
- NCT00559780
- Acronym / sponsor ID
- HKF:01058/00
- Keywords
- Resistance training, Aging, hip-surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- May 2000
- Study completion
- Dec 2003 (actual)
- First posted
- 16 Nov 2007 (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.
During the last decades there has been an increase in the relative proportion and life expectancy of elderly people in the industrialised countries. Consequently the amount of elderly with diseases and disabilities related to aging has increased. It therefore appears paramount to gain a better understanding of how disuse and immobilisation affects neuromuscular properties in the elderly, as well as to identify training regimes that ensures an effective rehabilitation.The population of interest in the present study was elderly individuals with long term hip-osteoarthritis undergoing a hip-replacement operation. The study was divided in two parts, a cross-sectional study and an intervention study.
The cross-sectional study investigated muscle size, maximal muscle strength, specific force, neural drive and explosive muscle force characteristics in elderly individuals who were affected by unilateral prolonged disuse due to hip-osteoarthritis. The data clearly indicated that the side with hip-osteoarthritis was affected by a marked decrease in muscle mass, maximal muscle strength, neural drive and explosive muscle force characteristics compared to the unaffected side.
The intervention study investigated if elderly patients that undergo hip-replacement surgery could benefit from additional training in the early postoperative phase. The data clearly demonstrated that resistance training was an effective and safe way to increase muscle mass, maximal muscle strength, neuromuscular activity, functional performance and decrease the hospitalisation period compared to regimes of conventional rehabilitation regimen or electrical muscle stimulation. Additionally the intervention study demonstrated that resistance training effectively induced marked increases in explosive muscle force characteristics in elderly subjects compared to rehabilitation regimes using electrical muscle stimulation or conventional rehabilitation. Furthermore, the gains in maximal muscle strength and explosive muscle force characteristics were accompanied by significant increases in EMG amplitudes. Furthermore, the demonstration that explosive muscle force capacity of the neuromuscular system remains trainable in elderly recovering from prolonged limb disuse and major surgery may have important implications for future rehabilitation programs, especially when considering the importance of rapid muscle force capacity on postural balance, maximal walking speed and other tasks of daily life actions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Resistance training12 weeks of resistance training |
| 2 | Experimental | Behavioral: Neuromuscular electrical stimulation of the quadriceps muscle12 weeks of neuromuscular electrical stimulation |
| 3 | Other | Behavioral: Standard rehabilitation12 weeks of standard rehabilitation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 60 years
- Unilateral primary hip replacement due to hip osteoarthritis in patients
Key exclusion criteria (1 listed)
- Cardiopulmonary, neurological or cognitive problems
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 |
|---|---|---|
| Resistance training12 weeks of resistance training (3/week) | Behavioural | 1 |
| Neuromuscular electrical stimulation of the quadriceps muscle12 weeks of neuromuscular electrical stimulation of the quadriceps muscle (1h/day) | Behavioural | 2 |
| Standard rehabilitation12 weeks of standard physiotherapy exercises (1h/day) | Behavioural | 3 |
Primary outcome
Not reported in the source record.
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 16 Nov 2007.
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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.
Charlotte Suetta, MD, PhD principal investigator
Institute of Sports Medicine copenhagen, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training, Neuromuscular electrical stimulation of the quadriceps muscle and Standard rehabilitation in people with Rehabilitation Strategies for Elderly Post-Operative Patients, run by Bispebjerg Hospital 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 1 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 16 Nov 2007. 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.
Where can I read the original study information?
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 16 Nov 2007; AzTrials last refreshed its copy on 27 Oct 2026.