Geriatric AssessmentEarly Phase 1NCT01086592
Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age
A Early Phase 1 study testing Strong progressive strengthening exercises of lower limbs, Electrotherapy and Electrotherapy+weights in people with Geriatric Assessment and Muscle Strength, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Assessment, Muscle Strength, Postural Balance
- What is being tested?
- Strong progressive strengthening exercises of lower limbs, Electrotherapy and Electrotherapy+weights
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Jun 2010
- Phase
- Early Phase 1
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age above 75
Who cannot join
- Mental disorder
- Previous electrotherapy treatments
- Pacemakers
- Lower limbs prosthetics
- Major coronary diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years.
- Being tested
- No intervention, Strong progressive strengthening exercises of lower limbs, Electrotherapy, Electrotherapy+weights
- Keywords
- Aged, Strength, Balance, Electrotherapy, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Daily life activities
Strong progressive strengthening exercises of lower limbsOther
Lower limb weight
ElectrotherapyOther
Neuromuscular Electrical Nerve Stimulation
Electrotherapy+weightsOther
Superimposed Neuromuscular Electric Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: No intervention |
| Strengthening exercise | Experimental | Strong progressive strengthening exercises of lower limbs. Receives: Other: Strong progressive strengthening exercises of lower limbs |
| Electrotherapy | Experimental | Neuromuscular Electrical Nerve Stimulation Receives: Other: Electrotherapy |
| Electrotherapy+weights | Experimental | Not described Receives: Other: Electrotherapy+weights |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB.
Measured: 3 months
Secondary outcomes (5)
Strength in lower limbs
Dinamometry, bioimpedancy.
Measured: 3 months
Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand
Berg Scale, SPPB.
Measured: 3 months
Maximum Gait Speed. Time to cover a 4 meter distance
Physical performance test
Measured: 3 months
Body mass index
Bioimpedancy, ecography, lower limb perimeter.
Measured: 3 months
Six-minute walking test
Physical performance test, assessing maximum distance covered during 6 minutes (assistance allowed if required).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Geriatric AssessmentStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Investigators
- Javier Romero, Dean, Study director, Facultad Ciencias Salud CEU-UCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086592
- Sponsor's protocol ID
- CEU-UCH-87
- Status last verified
- Jun 2010
- First submitted
- 9 Mar 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
PubMed 15304540Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.
PubMed 15730336Caggiano E, Emrey T, Shirley S, Craik RL. Effects of electrical stimulation or voluntary contraction for strengthening the quadriceps femoris muscles in an aged male population. J Orthop Sports Phys Ther. 1994 Jul;20(1):22-8. doi: 10.2519/jospt.1994.20.1.22.
PubMed 8081406Hunter GR, McCarthy JP, Bamman MM. Effects of resistance training on older adults. Sports Med. 2004;34(5):329-48. doi: 10.2165/00007256-200434050-00005.
PubMed 15107011Paillard T, Noe F, Passelergue P, Dupui P. Electrical stimulation superimposed onto voluntary muscular contraction. Sports Med. 2005;35(11):951-66. doi: 10.2165/00007256-200535110-00003.
PubMed 16271009Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. Effects of three different low-intensity exercise interventions on physical performance, muscle CSA and activities of daily living: a randomized controlled trial. Exp Gerontol. 2014 Oct;58:159-65. doi: 10.1016/j.exger.2014.08.004. Epub 2014 Aug 15.
PubMed 25131453
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age
- ClinicalTrials.gov ID
- NCT01086592
- Acronym / sponsor ID
- CEU-UCH-87
- Keywords
- Aged, Strength, Balance, Electrotherapy, Quality of life
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Mar 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.
The purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: No intervention |
| Strengthening exercise | Experimental | Other: Strong progressive strengthening exercises of lower limbsStrong progressive strengthening exercises of lower limbs. |
| Electrotherapy | Experimental | Other: ElectrotherapyNeuromuscular Electrical Nerve Stimulation |
| Electrotherapy+weights | Experimental | Other: Electrotherapy+weights |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age above 75
Key exclusion criteria (5 listed)
- Mental disorder
- Previous electrotherapy treatments
- Pacemakers
- Lower limbs prosthetics
- Major coronary diseases
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 |
|---|---|---|
| No interventionDaily life activities | Other | Control |
| Strong progressive strengthening exercises of lower limbsLower limb weight | Other | Strengthening exercise |
| ElectrotherapyNeuromuscular Electrical Nerve Stimulation | Other | Electrotherapy |
| Electrotherapy+weightsSuperimposed Neuromuscular Electric Nerve Stimulation | Other | Electrotherapy+weights |
Primary outcome
Functional Capacity
Time frame: 3 months
Berg's Scale, SF-36 test, 6 minute walking test, Barthel test, SPPB.
5 secondary outcomes
Strength in lower limbs
Time frame: 3 months
Timed standing balance. Side by side, semi tandem, tandem stand and one-leg stand
Time frame: 3 months
Maximum Gait Speed. Time to cover a 4 meter distance
Time frame: 3 months
Body mass index
Time frame: 3 months
Six-minute walking test
Time frame: 3 months
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 5 Jul 2010.
- Background: PubMed 15304540Barry BK, Carson RG. The consequences of resistance training for movement control in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):730-54. doi: 10.1093/gerona/59.7.m730.
- Background: PubMed 15730336Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.
- Background: PubMed 8081406Caggiano E, Emrey T, Shirley S, Craik RL. Effects of electrical stimulation or voluntary contraction for strengthening the quadriceps femoris muscles in an aged male population. J Orthop Sports Phys Ther. 1994 Jul;20(1):22-8. doi: 10.2519/jospt.1994.20.1.22.
- Background: PubMed 15107011Hunter GR, McCarthy JP, Bamman MM. Effects of resistance training on older adults. Sports Med. 2004;34(5):329-48. doi: 10.2165/00007256-200434050-00005.
- Background: PubMed 16271009Paillard T, Noe F, Passelergue P, Dupui P. Electrical stimulation superimposed onto voluntary muscular contraction. Sports Med. 2005;35(11):951-66. doi: 10.2165/00007256-200535110-00003.
- Derived from this study: PubMed 25131453Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. Effects of three different low-intensity exercise interventions on physical performance, muscle CSA and activities of daily living: a randomized controlled trial. Exp Gerontol. 2014 Oct;58:159-65. doi: 10.1016/j.exger.2014.08.004. Epub 2014 Aug 15.
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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.
Javier Romero, Dean study director
Facultad Ciencias Salud CEU-UCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Strong progressive strengthening exercises of lower limbs, Electrotherapy and Electrotherapy+weights in people with Geriatric Assessment and Muscle Strength, run by Cardenal Herrera University at 1 site in Spain.
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 1 inclusion and 5 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 5 Jul 2010. 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 Spain. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional Capacity (time frame: 3 months). 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 NCT01086592, which also lists 6 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 5 Jul 2010.