Muscle TightnessNCT05785416
Stretching Techniques of Knee Muscles and Their Effect on Joint Range, Suppleness and Muscle Activity in Elderly
A study testing Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR) and Static Stretching (SS) in people with Muscle Tightness and Muscle Weakness, run by Deepak Malhotra at 1 site in India.
Trial summary
The goal of this clinical trial was to compare the effect of two different types of stretching techniques in elderly population. The main questions it aims to answer are: 1. What is the immediate effect (after a single intervention) of these stretching techniques on muscle flexibility, amount of knee joint motion and… Read more about this study
- Who is it for?
- Ages 55 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness, Muscle Weakness
- What is being tested?
- Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR) and Static Stretching (SS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2018to 24 Jan 2019
- 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 55 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male adults aged between 55 and 75 years
- Able to do activities of daily living (ADL) without assistance
- Able to comprehend and follow instructions
Who cannot join
- Grade III or IV osteoarthritis or any other musculoskeletal condition affecting the muscle length.
- History of any surgery to hip, knee, low back or ankle
- History of any medication (anti-inflammatory, for pain relief, or anti-arthritic) in previous six months
- History of life-threatening disease (neurological disease, cardiovascular disease, severe hypertension)
- Passive full knee extension (popliteal angle 180 degrees)
Trial locations and contacts
1 site in 1 country.
India1 site
Out Patient Department, Centre for Physiotherapy & Rehabilitation Sciences, Jamia Millia Islamia
New Delhi, National Capital Territory of Delhi, 110025
About this study
Official title: Effects of Proprioceptive Neuromuscular Facilitation on Joint Range of Motion, Flexibility and Electromyographic Activity of Knee Muscles in Older Adults
The goal of this clinical trial was to compare the effect of two different types of stretching techniques in elderly population. The main questions it aims to answer are:
- What is the immediate effect (after a single intervention) of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity?
- What is the effect of a four week intervention program of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity? There were three groups with ten randomly allocated participants in each group. Intervention group I was given a stretching technique called contract-relax technique and the Intervention group II was given static stretching. The third group was not given any treatment and was taken as a control. The main aim was to find out that whether the two techniques are effective or not and which one of the two is better than the other in terms of improvement in the above mentioned parameters.
Read the detailed description
The objective of the study was to compare the effects of Proprioceptive Neuromuscular Facilitation - Contract Relax (PNF- CR) and static stretch techniques immediately and post four weeks of intervention on knee range of motion, flexibility and electromyographic activity of knee muscles among older adults. This is an outcome assessor-blinded pre-test post-test randomized controlled trial with two experimental groups (PNF-CR and Static Stretching) and a control group. 30 males aged 55-75 years were randomly assigned into PNF group (n=10), Static Stretch group (n=10) and Control group (n=10). Knee range of motion, electromyographic activity of hamstrings and sit and reach test, were taken for the dominant side thrice: pre-intervention, immediately after stretching and after the training period. Active knee range of motion (ROM) was assessed using a universal goniometer. Surface Electromyography (EMG) was used to record Maximal voluntary isometric contraction (MVIC) of biceps femoris and the Chair Sit-and-Reach Test (CART) was used to assess the hamstring muscle's length flexibility.
- Conditions
- Muscle Tightness, Muscle Weakness
- Being tested
- Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR), Static Stretching (SS)
- Keywords
- Contract Relax, Proprioceptive Neuromuscular Facilitation, Electromyography, Elderly, Flexibility, Range of Motion
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR)Other
PNF-CR utilized the concept of autogenic inhibition of the muscle for improving the flexibility of the muscle. It includes stretching a muscle after a brief period of activation.
Static Stretching (SS)Other
The SS technique utilized the concept of creep for improving the hamstring flexibility. The stretch was maintained for a prolonged period passively by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| PNF- CR Group | Experimental | The participants in the group were given PNF contract- relax stretching using the standard protocol. One trial had two isometric contractions each followed by five seconds muscle stretch and there was a total of four trials. Total of 12 sessions in 4 weeks (3sessions/week). Receives: Other: Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR) |
| Static Stretching Group | Experimental | The participants in the group were given sustained stretching for a period of 80s at a stretch.
Total of 12 sessions in 4 weeks (3sessions/week). Receives: Other: Static Stretching (SS) |
| Control Group | No intervention | No intervention was given in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active Knee Range of Motion
The active extension knee range of motion was measured using a universal goniometer.
Measured: Baseline, After 1st intervention (immediate), 4 weeks after intervention
Change in Maximum Voluntary Isometric Contraction (MVIC)
The Electromyographic activity of the biceps femoris muscle was evaluated using the surface electrodes during the maximal isometric contraction.
Measured: Baseline, After 1st intervention (immediate), 4 weeks after intervention
Secondary outcomes (1)
Change in Hamstring flexibility
The hamstring flexibility was measured using the Chair Sit and Reach Test (CART)
Measured: Baseline, After 1st intervention (immediate), 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Mar 2018
- Primary completion28 Nov 2018
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TightnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 males aged 55-75 years were randomly assigned into 3 arms - PNF group (n=10), Static Stretch group (n=10) and Control group (n=10)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepak Malhotra
- Sponsor type
- University, hospital or other
- Collaborators
- Jamia Millia Islamia
- Responsible party
- Sponsor-investigator, Deepak Malhotra, Jamia Hamdard University
- Investigators
- Sahar Zaidi, MPT, Principal investigator, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785416
- Sponsor's protocol ID
- 16/9/121/JMI/IEC/2017
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation on Joint Range of Motion, Flexibility and Electromyographic Activity of Knee Muscles in Older Adults
- ClinicalTrials.gov ID
- NCT05785416
- Acronym / sponsor ID
- 16/9/121/JMI/IEC/2017
- Conditions
- Muscle Tightness, Muscle Weakness
- Keywords
- Contract Relax, Proprioceptive Neuromuscular Facilitation, Electromyography, Elderly, Flexibility, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Deepak MalhotraUniversity, hospital or other
- Collaborators
- Jamia Millia Islamia
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 27 Mar 2023 (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.
The goal of this clinical trial was to compare the effect of two different types of stretching techniques in elderly population. The main questions it aims to answer are:
- What is the immediate effect (after a single intervention) of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity?
- What is the effect of a four week intervention program of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity? There were three groups with ten randomly allocated participants in each group. Intervention group I was given a stretching technique called contract-relax technique and the Intervention group II was given static stretching. The third group was not given any treatment and was taken as a control. The main aim was to find out that whether the two techniques are effective or not and which one of the two is better than the other in terms of improvement in the above mentioned parameters.
Detailed description
The objective of the study was to compare the effects of Proprioceptive Neuromuscular Facilitation - Contract Relax (PNF- CR) and static stretch techniques immediately and post four weeks of intervention on knee range of motion, flexibility and electromyographic activity of knee muscles among older adults. This is an outcome assessor-blinded pre-test post-test randomized controlled trial with two experimental groups (PNF-CR and Static Stretching) and a control group. 30 males aged 55-75 years were randomly assigned into PNF group (n=10), Static Stretch group (n=10) and Control group (n=10). Knee range of motion, electromyographic activity of hamstrings and sit and reach test, were taken for the dominant side thrice: pre-intervention, immediately after stretching and after the training period. Active knee range of motion (ROM) was assessed using a universal goniometer. Surface Electromyography (EMG) was used to record Maximal voluntary isometric contraction (MVIC) of biceps femoris and the Chair Sit-and-Reach Test (CART) was used to assess the hamstring muscle's length flexibility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 30 males aged 55-75 years were randomly assigned into 3 arms - PNF group (n=10), Static Stretch group (n=10) and Control group (n=10)
| Arm | Type | Receives |
|---|---|---|
| PNF- CR Group | Experimental | Other: Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR)The participants in the group were given PNF contract- relax stretching using the standard protocol. One trial had two isometric contractions each followed by five seconds muscle stretch and there was a total of four trials. Total of 12 sessions in 4 weeks (3sessions/week). |
| Static Stretching Group | Experimental | Other: Static Stretching (SS)The participants in the group were given sustained stretching for a period of 80s at a stretch. Total of 12 sessions in 4 weeks (3sessions/week). |
| Control Group | No intervention | –No intervention was given in this group |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male adults aged between 55 and 75 years
- Able to do activities of daily living (ADL) without assistance
- Able to comprehend and follow instructions
Key exclusion criteria (5 listed)
- Grade III or IV osteoarthritis or any other musculoskeletal condition affecting the muscle length.
- History of any surgery to hip, knee, low back or ankle
- History of any medication (anti-inflammatory, for pain relief, or anti-arthritic) in previous six months
- History of life-threatening disease (neurological disease, cardiovascular disease, severe hypertension)
- Passive full knee extension (popliteal angle 180 degrees)
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 |
|---|---|---|
| Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR)PNF-CR utilized the concept of autogenic inhibition of the muscle for improving the flexibility of the muscle. It includes stretching a muscle after a brief period of activation. | Other | PNF- CR Group |
| Static Stretching (SS)The SS technique utilized the concept of creep for improving the hamstring flexibility. The stretch was maintained for a prolonged period passively by the therapist. | Other | Static Stretching Group |
Primary outcome
Change in Active Knee Range of Motion
Time frame: Baseline, After 1st intervention (immediate), 4 weeks after intervention
The active extension knee range of motion was measured using a universal goniometer.
Change in Maximum Voluntary Isometric Contraction (MVIC)
Time frame: Baseline, After 1st intervention (immediate), 4 weeks after intervention
The Electromyographic activity of the biceps femoris muscle was evaluated using the surface electrodes during the maximal isometric contraction.
1 secondary outcome
Change in Hamstring flexibility
Time frame: Baseline, After 1st intervention (immediate), 4 weeks after intervention
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 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Sahar Zaidi, MPT principal investigator
Jamia Millia Islamia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Stretching - Contract Relax stretching (PNF-CR) and Static Stretching (SS) in people with Muscle Tightness and Muscle Weakness, run by Deepak Malhotra at 1 site in India.
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 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 27 Mar 2023. 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 India. 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 Active Knee Range of Motion (time frame: Baseline, After 1st intervention (immediate), 4 weeks after intervention). 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?
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 27 Mar 2023.