Stretching Techniques of Knee Muscles and Their Effect on Joint Range, Suppleness and Muscle Activity in Elderly

March 24, 2023 updated by: Deepak Malhotra

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:

  1. What is the immediate effect (after a single intervention) of these stretching techniques on muscle flexibility, amount of knee joint motion and muscle activity?
  2. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110025
        • Out Patient Department, Centre for Physiotherapy & Rehabilitation Sciences, Jamia Millia Islamia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male adults aged between 55 and 75 years
  • Able to do activities of daily living (ADL) without assistance
  • Able to comprehend and follow instructions

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNF- CR Group
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).
Other: 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.
Experimental: Static Stretching Group

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).
Other: 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.
No Intervention: Control Group
No intervention was given in this group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, After 1st intervention (immediate), 4 weeks after intervention
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.
Baseline, After 1st intervention (immediate), 4 weeks after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hamstring flexibility
Time Frame: Baseline, After 1st intervention (immediate), 4 weeks after intervention
The hamstring flexibility was measured using the Chair Sit and Reach Test (CART)
Baseline, After 1st intervention (immediate), 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deepak Malhotra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jamia Millia Islamia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sahar Zaidi, MPT, Jamia Millia Islamia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16/9/121/JMI/IEC/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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