PainNLC2010NCT01421628
Enhancement of Physical Fitness in Older Adults
A study testing Fitness exercise program in people with Pain and Physical Impairment, run by Hanze University of Applied Sciences Groningen at 1 site in Netherlands.
Trial summary
Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Physical Impairment
- What is being tested?
- Fitness exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Nov 2010
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- For patients to be included in our study, they had to experience regular episodes of NLC and are in good mental health.
- The participants had to agree to the study protocol and complete the program.
- After eligibility was verified, written informed consent was obtained.
Who cannot join
- Older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Kinese Fysiotherapeuten
Appingedam, Provincie Groningen, 9934 JD
About this study
Official title: The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.
Read the detailed description
The ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and ADL performance. This circle can be reversed by physical exercise to increase physical fitness.
The goal of this research is to establish the effects of a trainings program on ADL performance, physical fitness and nocturnal cramps. Furthermore the characteristics from participants who benefit from the program will be investigated by the research.
The study design is a randomized intervention study. Participants are elderly people, age 65 years and older, without cognitive impairment.
Intervention: The intervention is a physical trainings program. The intensity is moderate, the frequency is daily and the total duration is 6 weeks. The control group will be provided with an education program.
Main parameters are: physical fitness, nocturnal cramp severity and frequency.
- Conditions
- Pain, Physical Impairment
- Being tested
- Fitness exercise program
- Keywords
- older adults, exercise, stretching, mobility
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness exercise programOther
Exercise program, daily frequency, duration of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Not described Receives: Other: Fitness exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness
Strength, balance
Measured: six weeks
ADL performance
Performance based ADL test
Measured: six weeks
Well being
Questionnaires like SF-36
Measured: six weeks
Nocturnal cramps
Visual analogue scale (VAS)
Measured: Six weeks
Secondary outcomes (1)
Frequency nocturnal cramp
Number of cramp attacks per day.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanze University of Applied Sciences Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Investigators
- Hank Hallegraeff, PT, MSc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421628
- Sponsor's protocol ID
- HanzeUnlc
- Acronym
- NLC2010
- Status last verified
- Dec 2010
- First submitted
- 19 Aug 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hallegraeff JM, van der Schans CP, de Ruiter R, de Greef MH. Stretching before sleep reduces the frequency and severity of nocturnal leg cramps in older adults: a randomised trial. J Physiother. 2012;58(1):17-22. doi: 10.1016/S1836-9553(12)70068-1.
PubMed 22341378
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Trainings Program on ADL Performance, Physical Fitness, Wellbeing, and Nocturnal Cramp in Elderly People
- ClinicalTrials.gov ID
- NCT01421628
- Acronym / sponsor ID
- NLC2010 / HanzeUnlc
- Conditions
- Pain, Physical Impairment
- Keywords
- older adults, exercise, stretching, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hanze University of Applied Sciences GroningenUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Aug 2011 (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.
Ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (NLC). Our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.
Detailed description
The ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and ADL performance. This circle can be reversed by physical exercise to increase physical fitness.
The goal of this research is to establish the effects of a trainings program on ADL performance, physical fitness and nocturnal cramps. Furthermore the characteristics from participants who benefit from the program will be investigated by the research.
The study design is a randomized intervention study. Participants are elderly people, age 65 years and older, without cognitive impairment.
Intervention: The intervention is a physical trainings program. The intensity is moderate, the frequency is daily and the total duration is 6 weeks. The control group will be provided with an education program.
Main parameters are: physical fitness, nocturnal cramp severity and frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: Fitness exercise program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- For patients to be included in our study, they had to experience regular episodes of NLC and are in good mental health.
- The participants had to agree to the study protocol and complete the program.
- After eligibility was verified, written informed consent was obtained.
Key exclusion criteria (1 listed)
- Older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.
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 |
|---|---|---|
| Fitness exercise programExercise program, daily frequency, duration of 6 weeks. | Other | exercise |
Primary outcome
Physical fitness
Time frame: six weeks
Strength, balance
ADL performance
Time frame: six weeks
Performance based ADL test
Well being
Time frame: six weeks
Questionnaires like SF-36
Nocturnal cramps
Time frame: Six weeks
Visual analogue scale (VAS)
1 secondary outcome
Frequency nocturnal cramp
Time frame: Six weeks
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 23 Aug 2011.
- Derived from this study: PubMed 22341378Hallegraeff JM, van der Schans CP, de Ruiter R, de Greef MH. Stretching before sleep reduces the frequency and severity of nocturnal leg cramps in older adults: a randomised trial. J Physiother. 2012;58(1):17-22. doi: 10.1016/S1836-9553(12)70068-1.
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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.
Hank Hallegraeff, PT, MSc principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness exercise program in people with Pain and Physical Impairment, run by Hanze University of Applied Sciences Groningen at 1 site in Netherlands.
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 3 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 23 Aug 2011. 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 Netherlands. 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?
Physical fitness (time frame: six weeks). The study lists 4 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 NCT01421628, which also lists 1 linked publication.
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 23 Aug 2011.