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

NCT05650437 | Completed DMC

• 1 other identifier: 66
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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,

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (2)

• T-score of mineral density of lumber spine

  measured by dual energy X-ray absorptiometry

  3 months from treatment

• 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

  3 months from treatment

Study Arms (2)

Ultraviolet therapy group

ACTIVE COMPARATOR

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

Device: Ultraviolet Radiation; Behavioral: Aerobic exercise; Dietary Supplement: Vitamin D supplementation

Non Ultraviolet therapy group

ACTIVE COMPARATOR

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

Behavioral: Aerobic exercise; Dietary Supplement: Vitamin D supplementation

Interventions

Ultraviolet Radiation DEVICE

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

Ultraviolet therapy group

Aerobic exercise BEHAVIORAL

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

Non Ultraviolet therapy group; Ultraviolet therapy group

Vitamin D supplementation DIETARY_SUPPLEMENT

Throughout three months, vitamin D supplements (800 IU) will be given to all postmenopausal women in both groups (A\&B)

Non Ultraviolet therapy group; Ultraviolet therapy group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are in good health. body mass index (BMI) ranged from 25 to 30 kg/m2, ages ranged from 50 to 60

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ahmed M Maged

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: December 30, 2022
• Primary Completion: September 13, 2023
• Study Completion: December 15, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)