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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05130372
Other study ID # 2017/17-39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date February 27, 2018

Study information

Verified date November 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: To compare the acute effects of different stretching methods on ankle joint range of motion (ROM) in older adults. Methods: A total of 78 subjects aged 65 years and older were randomly divided into three groups. After the 5-minute walk, the randomly assigned method was applied. Static Stretching Group; static stretching in 3x30sec, PNF Stretching Group; PNF contract-relax in 3x30sec and Roller Massage Group; roller massage in 3x30sec was performed. Immediately after the application, 10 minutes and 20 minutes after application, the range of motion of the ankle joint was measured in the weight-bearing lunge position.


Description:

It is planned to single-blind, randomized controlled study with before-after measurements. Considering the acute effects of stretching exercise for ankle dorsiflexion in older women, the effect size was calculated as 1.02. According to this effect size, it was planned to recruit 26 people to each group with 95% confidence level and 95% power, and 78 people in total would participate in the study. Ethics committee approval of the study was received from Dokuz Eylul University Non-Interventional Research Ethics Committee (with the decision number 2017/17-39 in the meeting dated 22.06.2017). The study was conducted under the Declaration of Helsinki standards. The participants were informed about the study by the physiotherapist and all the participants provided written informed consent to participate in the study. The study included healthy and voluntary older adults aged 65 and over who were able to walk without using an assistive device, independent in their daily life activities, and scored 23 and above according to the mini-mental state test in the study. The exclusion criteria of the study were the presence of a neurological, orthopedic or cardiovascular disease affecting the lower extremity, pain or limitation of movement in the ankle joint, skin diseases, history of falling in the last 1 year, any problem that may prevent lying prone and participation in a regular exercise program. Individuals meeting the inclusion criteria were randomly assigned to one of two different groups with the help of the Random Numbers Table. The study was terminated when the target number of participants (n=78) was reached. Static stretching was applied to the first group (n=26), PNF stretching to the second group (n=26), and roller massage to the third group (n=26). Individuals meeting the inclusion criteria were randomly assigned to one of two different groups with the help of the Random Numbers Table. The study was terminated when the target number of participants (n=78) was reached. Static stretching was applied to the first group (n=26), PNF stretching to the second group (n=26), and roller massage to the third group (n=26). (Figure 1) After the stretching method to be applied was determined randomly, the participants were asked to walk for 5 minutes in a 50-meter corridor. After warming up with this light-paced walking, applied one of the three methods. Immediately after the application, 10 minutes and 20 minutes after application, the range of motion of the ankle joint was measured in the weight-bearing lunge position.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date February 27, 2018
Est. primary completion date February 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Healthy and voluntary older adults aged 65 and over - Who were able to walk without using an assistive device, - Independent in their daily life activities - Who scored 23 and above according to the mini-mental state test. Exclusion Criteria: - Presence of a neurological, orthopedic or cardiovascular disease affecting the lower extremity, - Pain or limitation of movement in the ankle joint, - Skin diseases, - History of falling in the last 1 year, - Any problem that may prevent lying prone - participation in a regular exercise program.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Static Stretching Method Group
Static stretching has been the most common stretching method applied to the ankle in healthy older adults, and different protocols have proven to increase ankle range of motion. In this study, the static stretching method was actively applied while standing.
PNF Stretching Method Group
The contract-relax technique was used in the PNF stretching method.
Myofascial Relaxation Method Group- Roller Massage
A theraband roller massager (Theraband®, The Hygenic Corporation, Akron, OH) was used for the myofascial relaxation method.

Locations

Country Name City State
Turkey Izmir Provincial Health Directorate State Hospital Izmir Urla
Turkey Izmir Provincial Health Directorate Urla State Hospital Izmir Urla

Sponsors (3)

Lead Sponsor Collaborator
Hacettepe University Ceren Devrim Sahin, Nursen Ilçin

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position. Baseline
Primary Range of motion The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position. Immediately after application
Primary Range of motion The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position. 10 minutes after application
Primary Range of motion The ankle ROM measurement made in the standing load-bearing position and the measurement made in the weight-bearing position. 20 minutes after application
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