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Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women

Primary Purpose

Postmenopausal Osteoporosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultraviolet Radiation
Aerobic exercise
Vitamin D supplementation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal women who did not engage in any recreational physical activity in the previous three months Low bone mineral density (BMD) at their spine and/or femoral neck met the inclusion criteria. They are in good health. body mass index (BMI) ranged from 25 to 30 kg/m2, ages ranged from 50 to 60 Exclusion Criteria: mental, neurological, Vestibular, cardiovascular, metabolic disease, musculoskeletal disorders with lower limb deformity, visual or hearing impairment undergone hormone replacement therapy. any medication that affected their balance or photosensitizing medications like aspirin, tetracycline, and Chlorothiazide

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultraviolet therapy group

Non Ultraviolet therapy group

Arm Description

35 women will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months

35 women will undergo three weekly sessions of routine aerobic activity and vitamin D supplements (800 IU) daily for three months

Outcomes

Primary Outcome Measures

T-score of mineral density of lumber spine
measured by dual energy X-ray absorptiometry
Peak Torque of knee flexors and extensors
The isokinetic dynamometer for the Biodex System 3, Biodex Medical System, Shirley, New York, USA, was recommended to be used in the current study [11]. It was adopted in the study to evaluate the muscular strength of the knee flexors and extensors in all postmenopausal women in both groups

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
December 6, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05650437
Brief Title
Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women
Official Title
Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two groups by randomization. 35 postmenopausal women in Group (A) will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months. For three months, group (B), which consists of 35 postmenopausal women, will undergo daily aerobic exercise and vitamin D supplementation (800 IU) only. The amount of serum 25-hydroxyvitamin D was measured using ELISA kits, bone mineral density of lumber spine was measured by dual energy X-ray absorptiometry (DEXA), and the torque of knee flexors and extensors was evaluated using the Biodex System 3 isokinetic dynamometer,
Detailed Description
Group (A): This group covers a sum of 35 postmenopausal women who underwent three weekly sessions of UV light therapy in addition to daily vitamin D supplements of 800 IU. Ultraviolet therapy device It was an ultraviolet arc lamp made of a low-pressure mercury discharge tube with an internal phosphor coating. The chemical makeup of the phosphor utilized determined the specific wavelength and output of each light (mixtures of phosphates, borates, and silicates). This produces a sizable amount of UVA and UVB but none of UVC. The spectrum of the radiation: is 280-320 nm. Postmenopausal women in the group received treatment with quartz of the type 4004/2n- Verret (A). Using dose-response assessment, which is graded according to the individual's erythema response and is classified as E1, Second-degree erythema (E2), Third-degree erythema (E3), and Fourth-degree erythema, the physical therapist determined the postmenopausal woman's sensitivity to UV before applying UV (E4). The physical therapist instructed each case to wear safety glasses (goggles) to protect her eyes from UV, and treatment duration was calculated as a percentage of the MED of UV. The woman was then instructed to take off all of her clothes and wash her abdomen. After describing the steps to the woman and requesting that she avoid looking at the bulb due to the risk of eye damage. The therapist cut three holes, each measuring 2 by 2 cm, into a piece of cardboard that was about 4 by 20 cm in size. Subsequently, the region around the cardboard was covered with a cloth to prevent the skin nearby from being exposed to radiation by placing the cardboard on the abdomen. The lamp was turned on and positioned 70 cm away and perpendicular to the abdominal region. Before turning toward the woman, the arc lamp needed five to ten minutes to warm up and attain maximum power. The UV beam was pointed straight at the abdomen region after the lamp had achieved maximum power, which activated the timer. The three holes were exposed to UV light for 30 seconds at a time, after which two holes were covered and one was left unattended for the following 30 seconds. The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30 seconds by this protocol. Then, instruct the woman to document the region's reaction for 24 hours after exposure. The area that experienced minor skin reddening within eight hours and faded within twenty-four hours was given MED treatment. The minimum erythemal dose (MED) or E1 was the desired dose in this study. Following the determination of the MED for each woman, the UV session was conducted as follows: To maximize exposure of the portion being treated and prevent unnecessary exposure of other parts, the postmenopausal lady was directed to remove clothing from the lower abdomen and lie in a supine position. As for the rest of the body, which did not require exposure, it was covered. Goggles are necessary to shield the eyes from exposure. After that, the ultraviolet Arc lamp was adjusted so that it is positioned approximately 70 cm above the lower abdominal region in a perpendicular position. By the MED for each lady that was spotted, the lamp was switched on and the timer was changed. The lamp was turned off and moved away from the postmenopausal woman by the end of the therapy period. Any noticeable reaction to the therapy was recorded within the three treatment sessions per week which were administered for a total of three months. Aerobic exercise The postmenopausal women in groups (A and B) exercised on the treadmill; women should always warm up before beginning exercise and stop if they experience pain or shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and 20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that the circulatory system can support during physical exercise is MHR=220. Three sessions a week for three months, followed by a five-minute cool-down [10]. Vitamin D supplementation Throughout three months, vitamin D supplements (800 IU) were given to all postmenopausal women in both groups (A&B). The Group (B): This group comprises of 17 postmenopausal women who completed 3 months of daily aerobic exercise and vitamin D supplementation (800 IU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultraviolet therapy group
Arm Type
Active Comparator
Arm Description
35 women will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months
Arm Title
Non Ultraviolet therapy group
Arm Type
Active Comparator
Arm Description
35 women will undergo three weekly sessions of routine aerobic activity and vitamin D supplements (800 IU) daily for three months
Intervention Type
Device
Intervention Name(s)
Ultraviolet Radiation
Intervention Description
The therapist cut three holes, each measuring 2 by 2 cm, into a piece of cardboard that was about 4 by 20 cm in size.The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30 seconds
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
The postmenopausal women in groups (A and B) exercised on the treadmill; women should always warm up before beginning exercise and stop if they experience pain or shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and 20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that the circulatory system can support during physical exercise is MHR=220. Three sessions a week for three months, followed by a five-minute cool-down
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplementation
Intervention Description
Throughout three months, vitamin D supplements (800 IU) will be given to all postmenopausal women in both groups (A&B)
Primary Outcome Measure Information:
Title
T-score of mineral density of lumber spine
Description
measured by dual energy X-ray absorptiometry
Time Frame
3 months from treatment
Title
Peak Torque of knee flexors and extensors
Description
The isokinetic dynamometer for the Biodex System 3, Biodex Medical System, Shirley, New York, USA, was recommended to be used in the current study [11]. It was adopted in the study to evaluate the muscular strength of the knee flexors and extensors in all postmenopausal women in both groups
Time Frame
3 months from treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women who did not engage in any recreational physical activity in the previous three months Low bone mineral density (BMD) at their spine and/or femoral neck met the inclusion criteria. They are in good health. body mass index (BMI) ranged from 25 to 30 kg/m2, ages ranged from 50 to 60 Exclusion Criteria: mental, neurological, Vestibular, cardiovascular, metabolic disease, musculoskeletal disorders with lower limb deformity, visual or hearing impairment undergone hormone replacement therapy. any medication that affected their balance or photosensitizing medications like aspirin, tetracycline, and Chlorothiazide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Maged
Phone
+201005227404
Email
Ahmedmaged@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaa Kamal
Phone
+201006914119
Email
wafaa_kamal37@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Maged
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women

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