Muscle RelaxationFlexibilityNCT03350880
Stretching Isquiotibials in Water and on Land in Healthy Adutls
A study testing Flexibility training in people with Muscle Relaxation, run by Universidade Federal do vale do São Francisco at 1 site in Brazil.
Trial summary
Comparison of therapeutic intervention to gain range of motion at the hip joint within therapeutic in water and on land. Stretching is a therapeutic maneuver used to increase the length of shortened soft tissue structures and thereby gain range of motion; for that, innumerable procedures within Physiotherapy use it… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Flexibility training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2018to 1 Nov 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 60 years;
- sedentary and who did not perform physiotherapy and physical activity in the last three months;
- clinical and cognitive conditions for swimming pool activities and aerobic exercise; who have not undergone highly complex surgical procedures in the last six months;
- to be able of walking without help equipment and without musculoskeletal or skeletal diseases;
- without contraindications to the practice of exercises; such as: urinary and / or fecal incontinence and dermatological diseases;
- below obesity II with BMI <40.
Who cannot join
- if they have up to three consecutive fouls during the hydrogymnastics period;
- if they present any adverse effects, such as: allergy or any dermatitis;
- unable to continue the study due to change of address or hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Stretching Isquiotibials in Water and on Land in Healthy Adutls for Flexibility: a Randomized Controlled Trial.
Comparison of therapeutic intervention to gain range of motion at the hip joint within therapeutic in water and on land. Stretching is a therapeutic maneuver used to increase the length of shortened soft tissue structures and thereby gain range of motion; for that, innumerable procedures within Physiotherapy use it for the benefit of patients. The work in question is justified by the need to seek the means that can promote a better performance in the application of the stretching procedure, called Proprioceptive Neuromuscular Facilitation, in a universe of pre-selected volunteers. It is a relevant and feasible study, hoping that its results may benefit future patients, with better results and faster responses. What is the medium that leads to better results in a program using the proprioceptive neuromuscular facilitation technique? Hypotheses: a - Probably the heated aquatic environment, in a range of 32 ° to 36 ° C, will promote a better result, since the heat increases the collagen's distensibility. b - Perhaps the heat, by increasing the excitability threshold of nerve fibers, triggers the "protective reflex" later, which may promote a more vigorous elongation without the protective response. c - Possibly the relaxation promoted in the aquatic environment, could influence the gains obtained in the swimming pool.
Read the detailed description
Comparison of therapeutic intervention to gain range of motion at the hip joint within therapeutic in water and on land.
- Conditions
- Muscle Relaxation
- Being tested
- Flexibility training
- Keywords
- Passive, Stretching, Water, Proprioceptive Neuromuscular Facilitation (PNF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexibility trainingOther
Also called streching training
Flexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| PNF in Water - PNFW | Experimental | Flexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions. Receives: Other: Flexibility training |
| PNF on Land - PNFL | Active comparator | Flexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions. Receives: Other: Flexibility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
range of motion by goniometer
Measured: six weeks
Secondary outcomes (1)
sit and reach test
sit and reach test by wells bank
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 posted22 Nov 2017
- Study start1 Jan 2018
- Primary completion28 Aug 2018
- Study completion1 Nov 2018
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 Muscle RelaxationStudies 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
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do vale do São Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350880
- Sponsor's protocol ID
- 022017
- Acronym
- Flexibility
- Status last verified
- Jul 2022
- First submitted
- 18 Nov 2017
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Papers and abstract congress
Publications
Ribeiro, Hálisson Alves, et al.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stretching Isquiotibials in Water and on Land in Healthy Adutls for Flexibility: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03350880
- Acronym / sponsor ID
- Flexibility / 022017
- Conditions
- Muscle Relaxation
- Keywords
- Passive, Stretching, Water, Proprioceptive Neuromuscular Facilitation (PNF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do vale do São FranciscoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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.
Comparison of therapeutic intervention to gain range of motion at the hip joint within therapeutic in water and on land. Stretching is a therapeutic maneuver used to increase the length of shortened soft tissue structures and thereby gain range of motion; for that, innumerable procedures within Physiotherapy use it for the benefit of patients. The work in question is justified by the need to seek the means that can promote a better performance in the application of the stretching procedure, called Proprioceptive Neuromuscular Facilitation, in a universe of pre-selected volunteers. It is a relevant and feasible study, hoping that its results may benefit future patients, with better results and faster responses. What is the medium that leads to better results in a program using the proprioceptive neuromuscular facilitation technique? Hypotheses: a - Probably the heated aquatic environment, in a range of 32 ° to 36 ° C, will promote a better result, since the heat increases the collagen's distensibility. b - Perhaps the heat, by increasing the excitability threshold of nerve fibers, triggers the "protective reflex" later, which may promote a more vigorous elongation without the protective response. c - Possibly the relaxation promoted in the aquatic environment, could influence the gains obtained in the swimming pool.
Detailed description
Comparison of therapeutic intervention to gain range of motion at the hip joint within therapeutic in water and on land.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| PNF in Water - PNFW | Experimental | Other: Flexibility trainingFlexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions. |
| PNF on Land - PNFL | Active comparator | Other: Flexibility trainingFlexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age between 18 and 60 years;
- sedentary and who did not perform physiotherapy and physical activity in the last three months;
- clinical and cognitive conditions for swimming pool activities and aerobic exercise; who have not undergone highly complex surgical procedures in the last six months;
- to be able of walking without help equipment and without musculoskeletal or skeletal diseases;
- without contraindications to the practice of exercises; such as: urinary and / or fecal incontinence and dermatological diseases;
Key exclusion criteria (3 listed)
- if they have up to three consecutive fouls during the hydrogymnastics period;
- if they present any adverse effects, such as: allergy or any dermatitis;
- unable to continue the study due to change of address or hospitalization.
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 |
|---|---|---|
| Flexibility trainingAlso: streching trainingFlexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions. | Other | PNF in Water - PNFW, PNF on Land - PNFL |
Primary outcome
range of motion
Time frame: six weeks
range of motion by goniometer
1 secondary outcome
sit and reach test
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 29 Jul 2022.
- Results publicationRibeiro, Hálisson Alves, et al.
- Individual participant dataSharing planned: Yes. Papers and abstract congress
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexibility training in people with Muscle Relaxation, run by Universidade Federal do vale do São Francisco at 1 site in Brazil.
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 6 inclusion and 3 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 29 Jul 2022. 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 Brazil. 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?
range of motion (time frame: six weeks). 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 NCT03350880, 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 29 Jul 2022.