Hydrocephalus, Normal PressureiNPhysNCT02659111
Effects of Physical Training in iNPH
A study testing High Intensive Functional Exercise (HIFE) and Physical training advice in people with Hydrocephalus, Normal Pressure, run by Linkoeping University at 1 site in Sweden.
Trial summary
Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties regarding gait, balance, cognition and micturition. A shunt operation will improve these difficulties in most cases. Data suggest however, that they do not change their physical activity postoperatively. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hydrocephalus, Normal Pressure
- What is being tested?
- High Intensive Functional Exercise (HIFE) and Physical training advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to Jan 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005
Who cannot join
- MMSE: equal to and below 16 and/or inability to walk, with or without support , for 10 m.
- Other disease, e.g severe heart disease, asthma making intensive physical training impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties regarding gait, balance, cognition and micturition. A shunt operation will improve these difficulties in most cases. Data suggest however, that they do not change their physical activity postoperatively. Physical training has been shown to be beneficial in patients with similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical training program after a shunt operation to see if the patients can improve their physical capacity and ambulatory activity more than patients who only receive standardized written advice about physical training.
Read the detailed description
Consecutive patients with iNPH at the neurological departments of University Hospital of Linköping and at Sahlgrenska University Hospital are included and randomized for either physical training according to a validated training concept for elderly and cognitive impaired patients named HIFE ( High Intensity Functional Exercise) together with a standardized written instruction for home training of physical exercises or only a standardized written instruction for home training. Goal Attainment Scaling will be used to set measurable goals together with the patient. The training will take place in a facility where physiotherapists are available either at the two centers or close to the patient´s home.Those physiotherapists at the centers responsible for the training will contact and send the local physiotherapists a manual and give instructions about the HIFE concept and will also stay in contact for the whole intervention i.e. 12 weeks ( one hour two times a week). A minimum of 18 out of 24 session will be required.
- Conditions
- Hydrocephalus, Normal Pressure
- Being tested
- High Intensive Functional Exercise (HIFE), Physical training advice
- Keywords
- Exercise Therapy
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensive Functional Exercise (HIFE)Other
Patients invited to high-intensity physical exercise, HIFE by a physiotherapist with special competence in neurology at one of the two centers, or by a general physiotherapist where the patient lives. Goal Attainment Scaling is performed. The training will be given twice a week for one hour during 12 weeks . At least 18 of 24 training session in a four month period of time will be required. A training manual will be distributed to each training physiotherapist. The patients will also be encouraged to do additional training and they will receive standardized written physical training advice
Physical training adviceOther
Patients randomized to written advice for physical training will be given a leaflet with instructions how to train by there own.The physiotherapist responsible for evaluating sets goals together with the patient according to Goal Attainment Scaling.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity physical exercise, HIFE | Experimental | Not described Receives: Other: High Intensive Functional Exercise (HIFE); Other: Physical training advice |
| Physical training advice | Active comparator | Not described Receives: Other: Physical training advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in iNPH-scale
iNPH-scale (Hellström et al) is a validated scale consisting of four domains; balance, gait, cognition and micturition to evaluate severity of iNPH.
Measured: 3 and 6 months postoperatively
Change in GAS
Goal Attainment Scaling. A goal i set and an assessment is made according to a five-graded scale defining in what degree the goal is achieved.
Measured: 3 and 6 months postoperatively
Secondary outcomes (12)
Quality of life
EQ-5D-5L
Measured: 3 and 6 months postoperatively
Depression
Beck Depression Inventory II
Measured: 3 and 6 months postoperatively
Disability
Modified Rankin Scale
Measured: 3 and 6 months postoperatively
Muscle strengths
The test is called "Chair-stand test". Leg strengths is measured, by counting number of raising ups from sitting to standing, that the research person is able to in 30 sec.
Measured: 3 and 6 months postoperatively
Physical endurance test
Testing the distance a person is able to walk in 6 min
Measured: 3 and 6 months postoperatively
Falls
Registration of the actual number of falls in the last three months
Measured: 3 and 6 months postoperatively
Actigraphy
Actigraphy is a method to evaluate physical activity in a research person´s normal life. SenseWear is used to record number of steps daily but also time spent lying and standing which will give information about the activity.
Measured: 3 and 6 months postoperatively
Balance
Timed Up and Go
Measured: 3 and 6 months postoperatively
ADL
ADL taxonomy
Measured: 3 and 6 months postoperatively
Activity
Grimby 6
Measured: 3 and 6 months postoperatively
Life satisfaction
LiSat 11 is a validated questionnaire with 11 items concerning different aspects of quality of life,.
Measured: 3 and 6 months postoperatively
Diurnal rhythm
Actigraphy (SenseWear) is used for one week. Diurnal rhythm will be assessed by measuring the peak amplitude of acitivity daily, the mean amplitude of activity daily and the 24 hour period.
Measured: 3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus, Normal PressureStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Fredrik Lundin, Linkoeping University
- Investigators
- Fredrik Lundin, MD, PhD, Principal investigator, Dept of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659111
- Sponsor's protocol ID
- Dnr 205/250-31
- Acronym
- iNPhys
- Status last verified
- Mar 2020
- First submitted
- 12 Jan 2016
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rydja J, Kollen L, Ulander M, Tullberg M, Lundin F. Physical Capacity and Activity in Patients With Idiopathic Normal Pressure Hydrocephalus. Front Neurol. 2022 Mar 28;13:845976. doi: 10.3389/fneur.2022.845976. eCollection 2022.
PubMed 35418936Rydja J, Kollen L, Hellstrom P, Owen K, Lundgren Nilsson A, Wikkelso C, Tullberg M, Lundin F. Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial. Fluids Barriers CNS. 2021 Nov 22;18(1):51. doi: 10.1186/s12987-021-00287-8.
PubMed 34809666
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Training in Shunt-operated Patients With Idiopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT02659111
- Acronym / sponsor ID
- iNPhys / Dnr 205/250-31
- Conditions
- Hydrocephalus, Normal Pressure
- Keywords
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 20 Jan 2016 (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.
Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties regarding gait, balance, cognition and micturition. A shunt operation will improve these difficulties in most cases. Data suggest however, that they do not change their physical activity postoperatively. Physical training has been shown to be beneficial in patients with similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical training program after a shunt operation to see if the patients can improve their physical capacity and ambulatory activity more than patients who only receive standardized written advice about physical training.
Detailed description
Consecutive patients with iNPH at the neurological departments of University Hospital of Linköping and at Sahlgrenska University Hospital are included and randomized for either physical training according to a validated training concept for elderly and cognitive impaired patients named HIFE ( High Intensity Functional Exercise) together with a standardized written instruction for home training of physical exercises or only a standardized written instruction for home training. Goal Attainment Scaling will be used to set measurable goals together with the patient. The training will take place in a facility where physiotherapists are available either at the two centers or close to the patient´s home.Those physiotherapists at the centers responsible for the training will contact and send the local physiotherapists a manual and give instructions about the HIFE concept and will also stay in contact for the whole intervention i.e. 12 weeks ( one hour two times a week). A minimum of 18 out of 24 session will be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity physical exercise, HIFE | Experimental | Other: High Intensive Functional Exercise (HIFE), Other: Physical training advice |
| Physical training advice | Active comparator | Other: Physical training advice |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005
Key exclusion criteria (2 listed)
- MMSE: equal to and below 16 and/or inability to walk, with or without support , for 10 m.
- Other disease, e.g severe heart disease, asthma making intensive physical training impossible.
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 |
|---|---|---|
| High Intensive Functional Exercise (HIFE)Patients invited to high-intensity physical exercise, HIFE by a physiotherapist with special competence in neurology at one of the two centers, or by a general physiotherapist where the patient lives. Goal Attainment Scaling is performed. The training will be given twice a week for one hour during 12 weeks . At least 18 of 24 training session in a four month period of time will be required. A training manual will be distributed to each training physiotherapist. The patients will also be encouraged to do additional training and they will receive standardized written physical training advice | Other | High-intensity physical exercise, HIFE |
| Physical training advicePatients randomized to written advice for physical training will be given a leaflet with instructions how to train by there own.The physiotherapist responsible for evaluating sets goals together with the patient according to Goal Attainment Scaling. | Other | High-intensity physical exercise, HIFE, Physical training advice |
Primary outcome
Change in iNPH-scale
Time frame: 3 and 6 months postoperatively
iNPH-scale (Hellström et al) is a validated scale consisting of four domains; balance, gait, cognition and micturition to evaluate severity of iNPH.
Change in GAS
Time frame: 3 and 6 months postoperatively
Goal Attainment Scaling. A goal i set and an assessment is made according to a five-graded scale defining in what degree the goal is achieved.
12 secondary outcomes
Quality of life
Time frame: 3 and 6 months postoperatively
Depression
Time frame: 3 and 6 months postoperatively
Disability
Time frame: 3 and 6 months postoperatively
Muscle strengths
Time frame: 3 and 6 months postoperatively
Physical endurance test
Time frame: 3 and 6 months postoperatively
Falls
Time frame: 3 and 6 months postoperatively
Actigraphy
Time frame: 3 and 6 months postoperatively
Balance
Time frame: 3 and 6 months postoperatively
ADL
Time frame: 3 and 6 months postoperatively
Activity
Time frame: 3 and 6 months postoperatively
Life satisfaction
Time frame: 3 and 6 months postoperatively
Diurnal rhythm
Time frame: 3 and 6 months postoperatively
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 9 Mar 2020.
- Derived from this study: PubMed 35418936Rydja J, Kollen L, Ulander M, Tullberg M, Lundin F. Physical Capacity and Activity in Patients With Idiopathic Normal Pressure Hydrocephalus. Front Neurol. 2022 Mar 28;13:845976. doi: 10.3389/fneur.2022.845976. eCollection 2022.
- Derived from this study: PubMed 34809666Rydja J, Kollen L, Hellstrom P, Owen K, Lundgren Nilsson A, Wikkelso C, Tullberg M, Lundin F. Physical exercise and goal attainment after shunt surgery in idiopathic normal pressure hydrocephalus: a randomised clinical trial. Fluids Barriers CNS. 2021 Nov 22;18(1):51. doi: 10.1186/s12987-021-00287-8.
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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.
Fredrik Lundin, MD, PhD principal investigator
Dept of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensive Functional Exercise (HIFE) and Physical training advice in people with Hydrocephalus, Normal Pressure, run by Linkoeping University at 1 site in Sweden.
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 2 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 9 Mar 2020. 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 Sweden. 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?
Change in iNPH-scale (time frame: 3 and 6 months postoperatively). The study lists 2 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 NCT02659111, which also lists 2 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 9 Mar 2020.