Effect of PROGRESSive Training and Teststerone in Older Frail Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2023-03-31

Brief Summary

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In this scientific clinical investigation we will test whether testosterone and progressive resistance training can improve muscle strength and reduce the risk of falls in older men. In addition, we will examine whether this treatment improves quality of life, functional capacity, including sexual function and counteracts depression. Such a project have not been performed earlier.

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Detailed Description

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Project background: In Denmark more than 1,000 people each year die of a fall, which is more than five times as many dying in traffic accidents. Fall accidents are also the leading cause of traumatic brain injury and is a relatively unnoticed problem, although this type of accidents causes more hospital bed days than all other accidents combined.

Annually, almost half of the 375,000 elderly Danes over 75 years of age and relatively three times as many of the approximately 40,000 elderly people in nursing homes fall every year, causing over 40,000 hospital contacts annually. Ten percent of all elderly people hospitalized each year because of a fall, mostly with fractures, for which the risk increases fivefold after a fall. In Denmark there are now now around 1 million people over 65 years of age. Over the next 25 years we will experience a 50% growth to 1.5 million people over 65 years of age.

Injury, disability and death caused by falls is therefore a widespread and growing human and societal problem. Many will never recover completely and will therefore need help to cope with everyday life. After the first fall risk increase for repeated falls. Especially for older people living in their own homes permanent or temporary disabilities results in a severe deterioration of the quality of life. Treatment of falls is also a significant financial burden on health and social care.

The main reason for the decline is muscle weakness. Muscle weakness leads to greatly increased risk of falling, decreased quality of life and functional capacity. Musclemass and -power decrease about 40 percent from age 20 to 80 years old.

Recent studies have shown that even 90-year-old persons can double their muscle strength by intensive training just three times per week. The level of the male sex hormone testosterone decreases with age and leads to impaired muscle mass. Twenty percent of men over 60 and 50 percent over 80 years, a low level of testosterone in total equivalent to more than 100,000 Danes. From the human and socio-economic perspective, it is important to find treatments that can enhance function in the elderly.

Conditions

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Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Controls

A control group, which is 20 weeks with placebo injections without training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Testosterone

A testosterone group given 20 weeks on testosterone injections without training

Group Type EXPERIMENTAL

testosterone

Intervention Type DRUG

Testosterone supplemented in 5 months

Training

A Training Group, which is 20 weeks with placebo injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements

Group Type EXPERIMENTAL

Progressive muscle training

Intervention Type OTHER

Progressive muscle training during 4 months

Testosterone and training

A combination group that is 20 weeks with testosterone injections and 16 weeks of progressive resistance training supplemented with vitamin D and protein supplements

Group Type EXPERIMENTAL

testosterone

Intervention Type DRUG

Testosterone supplemented in 5 months

Progressive muscle training

Intervention Type OTHER

Progressive muscle training during 4 months

Interventions

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testosterone

Testosterone supplemented in 5 months

Intervention Type DRUG

Progressive muscle training

Progressive muscle training during 4 months

Intervention Type OTHER

Other Intervention Names

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Training

Eligibility Criteria

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Inclusion Criteria

Living in their own home or in sheltered accommodation. Independent gait possible. with tool. Capable of stand-up and sit in a chair at least 8 times in 30 sec. There must be at least 3 symptoms or objective findings of low testosterone . Serum testosterone \<10nmol /L as the average of two independent measurements

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Minimum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes