Kidney TransplantationNCT02345577
Whole-body Vibration Physiotherapy in Kidney Transplantation
A study testing Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention in people with Kidney Transplantation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Dec 2014to 17 Jul 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Kidney transplantation in the last 12 months
- Stable kidney function (eGFR>20 ml/min)
- No episode of acute rejection during the last 2 months
- Written informed consent
Who cannot join
- Inability to posture or to perform whole-body vibration therapy or MRS after transplantation
- Treatment with anabolic medication, fluorine, bisphosphonates, or hormone replacement therapy (estrogens, selective modulators of the estrogenic receptors) within the previous 3 months
- Treatment with high-dose steroid therapy due to acute rejection episode during the last 2 months before study inclusion
- Implanted devices (pacemakers, defibrillators, stents, etc.)
- Pregnancy
- Previous ophthalmic cataract surgery
Show all 9Show fewer
- Previous history of epilepsy
- Previous recent spine of leg fracture (last 3 months)
- Other individuals especially in need of protection (according to the Swiss Academy of Medical Sciences)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
Bern, 3010 Bern
About this study
Official title: Effects of Stochastic Whole-body Vibration Physiotherapy-WBV (Stochastic Resonance Physiotherapy-SRT) on Muscle Strength in Patients After Kidney Transplantation: a Pilot Study
Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions.
Stochastic whole body vibration (WBV) therapy is a relatively new form of movement physiotherapy that is used for strength training. Various clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density. To study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal transplantation, kidney transplant recipients will be enrolled and undergo WBV. The investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and muscular performance
Read the detailed description
Background
The increasing incidence of muscular wasting, bone disease, falls and related fractures are the price for excellent survival rates in transplanted patients. Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions.
Recently, stochastic whole-body vibration (WBV) has received much attention as a potential muscle-anabolic and anti-osteoporotic intervention. It is suggested that the randomized low-frequency signals produced during such training can activate otherwise high threshold afferent and efferent motor-neurons and thus may result in a considerable neuromuscular activation. Additionally, there data supporting peripherally-induced central biochemical activation, that meaning the production of CNS modulators due to application of mechanical exercise such as stochastic WBV. The result is a rapid (within minutes), transient force increase. Due to the high number of stimuli-repetitions, it is possible to increase muscle strength using shorter training times (<5 min) than with conventional physiotherapeutic methods (> 30 min). Several experimental and clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density.
Moreover, a population of renal transplant recipients has not yet been studied elsewhere.
WBV is a very appealing approach, foremost in subjects with limited physical activity; it represents a potentially simple and efficient training method for skeletal muscle and better functional performance, thus preventing falls and consequently fractures.
Objective
Primary:
- To determine the effect of post-transplantation stochastic WBV therapy on preservation of functional muscle strength.
Secondary:
To assess a) the efficacy of post-transplantation stochastic WBV on body balance b) the efficacy of post-transplantation stochastic WBV on preservation of lean muscle mass determined by Magnetic Resonance Spectroscopy (MRS) c) the changes in bone turnover markers in renal transplant recipients under stochastic WBV therapy d) the short-term safety of stochastic WBV therapy in renal transplant recipients.
Methods
Prospective, randomized, double-blinded, placebo-controlled setting.
Recruited individuals will be randomized in Group 1 (intervention) and in Group 2 (placebo). All participants will be evaluated monthly for occurrence of falls and fractures, and treatment-associated side effects. Testing will be performed upon study entry and at 3 and 6 months according to the following schedule:
Visit 1 (Baseline):
- Muscle strength measurement
- Neuromuscular tests (SPPBT)
- Magnetic resonance spectroscopy (MRS)
- Turnover Markers (blood) Visits 2 and 3 (after 3 and 6 months respectively): Identical to visit 1
- Conditions
- Kidney Transplantation
- Being tested
- Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention, Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention
- Keywords
- Kidney transplantation, Stochastic whole body vibration therapy, Muscle strength, Intramuscular lipid content, Intramyocellular lipid content, Short Physical Performance Battery Test, Prospective, randomised , double blind,placebo-controlled trial, Physical Therapy Modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic whole body vibration (WBV) therapy - Physiotherapeutical interventionOther
Physiotherapeutical intervention
Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical interventionOther
Sham physiotherapeutical intervention
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapeutical intervention | Active comparator | 3 WBV-sessions per week for 3 consecutive months. Each session consists of 5 series with a duration of 60 sec with 60 sec rest-time with vibration of increasing frequency starting at 1Hz / Noise 4 going up to 6Hz / Noise 5 depending on patients' tolerability and with a fixed 3mm amplitude. Receives: Other: Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention |
| Sham physiotherapeutical intervention | Sham comparator | 3 WBV-sessions per week for 3 consecutive months. Each session consists of 5 series with a duration of 60 sec with 60 sec rest-time at 1 Hz / Noise 1 and 3mm amplitude. Receives: Other: Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months
Measured: 6 months
Secondary outcomes (6)
Change of neuromuscular test (SPPBT)-score from baseline to 3 and 6 months
Measured: 6 months
Change of muscle mass from baseline to 3 and 6 months
Measured: 6 months
Change of intramuscular lipid content from baseline to 3 and 6 months
Measured: 6 months
Change of intramyocellular (calf) lipid content from baseline to 3 and 6 months
Measured: 6 months
Falls during study period
Measured: 6 months
Fractures during study period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start16 Dec 2014
- Primary completion1 Feb 2017
- Study completion17 Jul 2017
Why it stopped: Due to low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Spyridon Arampatzis, MD, Principal investigator, Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345577
- Sponsor's protocol ID
- 176/14
- Status last verified
- Oct 2017
- First submitted
- 19 Jan 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Streja E, Molnar MZ, Kovesdy CP, Bunnapradist S, Jing J, Nissenson AR, Mucsi I, Danovitch GM, Kalantar-Zadeh K. Associations of pretransplant weight and muscle mass with mortality in renal transplant recipients. Clin J Am Soc Nephrol. 2011 Jun;6(6):1463-73. doi: 10.2215/CJN.09131010. Epub 2011 Mar 17.
PubMed 21415312Lai CL, Tseng SY, Chen CN, Liao WC, Wang CH, Lee MC, Hsu PS. Effect of 6 months of whole body vibration on lumbar spine bone density in postmenopausal women: a randomized controlled trial. Clin Interv Aging. 2013;8:1603-9. doi: 10.2147/CIA.S53591. Epub 2013 Dec 4.
PubMed 24348029Rogan S, Hilfiker R, Schmid S, Radlinger L. Stochastic resonance whole-body vibration training for chair rising performance on untrained elderly: a pilot study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):468-73. doi: 10.1016/j.archger.2012.02.011. Epub 2012 Mar 16.
PubMed 22425243Rogan S, Hilfiker R, Herren K, Radlinger L, de Bruin ED. Effects of whole-body vibration on postural control in elderly: a systematic review and meta-analysis. BMC Geriatr. 2011 Nov 3;11:72. doi: 10.1186/1471-2318-11-72.
PubMed 22054046Calendo LR, Taeymans J, Rogan S. [Does muscle activation during whole-body vibration induce bone density improvement in postmenopausal women?--A systematic review]. Sportverletz Sportschaden. 2014 Sep;28(3):125-31. doi: 10.1055/s-0034-1366545. Epub 2014 May 14. German.
PubMed 24828509
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stochastic Whole-body Vibration Physiotherapy-WBV (Stochastic Resonance Physiotherapy-SRT) on Muscle Strength in Patients After Kidney Transplantation: a Pilot Study
- ClinicalTrials.gov ID
- NCT02345577
- Acronym / sponsor ID
- 176/14
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplantation, Stochastic whole body vibration therapy, Muscle strength, Intramuscular lipid content, Intramyocellular lipid content, Short Physical Performance Battery Test, Prospective, randomised , double blind,placebo-controlled trial, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 26 Jan 2015 (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.
Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions.
Stochastic whole body vibration (WBV) therapy is a relatively new form of movement physiotherapy that is used for strength training. Various clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density. To study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal transplantation, kidney transplant recipients will be enrolled and undergo WBV. The investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and muscular performance
Detailed description
Background
The increasing incidence of muscular wasting, bone disease, falls and related fractures are the price for excellent survival rates in transplanted patients. Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early post-transplantation period and suffer from increasing abnormalities of neuromuscular functions.
Recently, stochastic whole-body vibration (WBV) has received much attention as a potential muscle-anabolic and anti-osteoporotic intervention. It is suggested that the randomized low-frequency signals produced during such training can activate otherwise high threshold afferent and efferent motor-neurons and thus may result in a considerable neuromuscular activation. Additionally, there data supporting peripherally-induced central biochemical activation, that meaning the production of CNS modulators due to application of mechanical exercise such as stochastic WBV. The result is a rapid (within minutes), transient force increase. Due to the high number of stimuli-repetitions, it is possible to increase muscle strength using shorter training times (<5 min) than with conventional physiotherapeutic methods (> 30 min). Several experimental and clinical studies have shown that in addition to muscle function, WBV also improved body balance and bone mineral density.
Moreover, a population of renal transplant recipients has not yet been studied elsewhere.
WBV is a very appealing approach, foremost in subjects with limited physical activity; it represents a potentially simple and efficient training method for skeletal muscle and better functional performance, thus preventing falls and consequently fractures.
Objective
Primary:
- To determine the effect of post-transplantation stochastic WBV therapy on preservation of functional muscle strength.
Secondary:
To assess a) the efficacy of post-transplantation stochastic WBV on body balance b) the efficacy of post-transplantation stochastic WBV on preservation of lean muscle mass determined by Magnetic Resonance Spectroscopy (MRS) c) the changes in bone turnover markers in renal transplant recipients under stochastic WBV therapy d) the short-term safety of stochastic WBV therapy in renal transplant recipients.
Methods
Prospective, randomized, double-blinded, placebo-controlled setting.
Recruited individuals will be randomized in Group 1 (intervention) and in Group 2 (placebo). All participants will be evaluated monthly for occurrence of falls and fractures, and treatment-associated side effects. Testing will be performed upon study entry and at 3 and 6 months according to the following schedule:
Visit 1 (Baseline):
- Muscle strength measurement
- Neuromuscular tests (SPPBT)
- Magnetic resonance spectroscopy (MRS)
- Turnover Markers (blood) Visits 2 and 3 (after 3 and 6 months respectively): Identical to visit 1
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapeutical intervention | Active comparator | Other: Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention3 WBV-sessions per week for 3 consecutive months. Each session consists of 5 series with a duration of 60 sec with 60 sec rest-time with vibration of increasing frequency starting at 1Hz / Noise 4 going up to 6Hz / Noise 5 depending on patients' tolerability and with a fixed 3mm amplitude. |
| Sham physiotherapeutical intervention | Sham comparator | Other: Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention3 WBV-sessions per week for 3 consecutive months. Each session consists of 5 series with a duration of 60 sec with 60 sec rest-time at 1 Hz / Noise 1 and 3mm amplitude. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Kidney transplantation in the last 12 months
- Stable kidney function (eGFR>20 ml/min)
- No episode of acute rejection during the last 2 months
- Written informed consent
Key exclusion criteria (9 listed)
- Inability to posture or to perform whole-body vibration therapy or MRS after transplantation
- Treatment with anabolic medication, fluorine, bisphosphonates, or hormone replacement therapy (estrogens, selective modulators of the estrogenic receptors) within the previous 3 months
- Treatment with high-dose steroid therapy due to acute rejection episode during the last 2 months before study inclusion
- Implanted devices (pacemakers, defibrillators, stents, etc.)
- Pregnancy
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 |
|---|---|---|
| Stochastic whole body vibration (WBV) therapy - Physiotherapeutical interventionPhysiotherapeutical intervention | Other | Physiotherapeutical intervention |
| Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical interventionSham physiotherapeutical intervention | Other | Sham physiotherapeutical intervention |
Primary outcome
Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months
Time frame: 6 months
6 secondary outcomes
Change of neuromuscular test (SPPBT)-score from baseline to 3 and 6 months
Time frame: 6 months
Change of muscle mass from baseline to 3 and 6 months
Time frame: 6 months
Change of intramuscular lipid content from baseline to 3 and 6 months
Time frame: 6 months
Change of intramyocellular (calf) lipid content from baseline to 3 and 6 months
Time frame: 6 months
Falls during study period
Time frame: 6 months
Fractures during study period
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Background: PubMed 21415312Streja E, Molnar MZ, Kovesdy CP, Bunnapradist S, Jing J, Nissenson AR, Mucsi I, Danovitch GM, Kalantar-Zadeh K. Associations of pretransplant weight and muscle mass with mortality in renal transplant recipients. Clin J Am Soc Nephrol. 2011 Jun;6(6):1463-73. doi: 10.2215/CJN.09131010. Epub 2011 Mar 17.
- Background: PubMed 24348029Lai CL, Tseng SY, Chen CN, Liao WC, Wang CH, Lee MC, Hsu PS. Effect of 6 months of whole body vibration on lumbar spine bone density in postmenopausal women: a randomized controlled trial. Clin Interv Aging. 2013;8:1603-9. doi: 10.2147/CIA.S53591. Epub 2013 Dec 4.
- Background: PubMed 22425243Rogan S, Hilfiker R, Schmid S, Radlinger L. Stochastic resonance whole-body vibration training for chair rising performance on untrained elderly: a pilot study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):468-73. doi: 10.1016/j.archger.2012.02.011. Epub 2012 Mar 16.
- Background: PubMed 22054046Rogan S, Hilfiker R, Herren K, Radlinger L, de Bruin ED. Effects of whole-body vibration on postural control in elderly: a systematic review and meta-analysis. BMC Geriatr. 2011 Nov 3;11:72. doi: 10.1186/1471-2318-11-72.
- Background: PubMed 24828509Calendo LR, Taeymans J, Rogan S. [Does muscle activation during whole-body vibration induce bone density improvement in postmenopausal women?--A systematic review]. Sportverletz Sportschaden. 2014 Sep;28(3):125-31. doi: 10.1055/s-0034-1366545. Epub 2014 May 14. German.
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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.
Spyridon Arampatzis, MD principal investigator
Department of Nephrology, Hypertension and Clinical Pharmacology, Bern University 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 Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention in people with Kidney Transplantation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Oct 2017. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Due to low recruitment rate). Results are not available in the source record.
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?
Change in maximal isometric strength of the leg extensors from baseline to 3 and 6 months (time frame: 6 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 NCT02345577, which also lists 5 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 25 Oct 2017.