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Trial registered on ANZCTR


Registration number
ACTRN12617000716369
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
17/05/2017
Date last updated
17/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of detraining on physical condition and quality of life in elderly habitual exercisers
Scientific title
Effect of detraining on physical condition, biochemical parameters and quality of life in elderly habitual exercisers
Secondary ID [1] 291795 0
none
Universal Trial Number (UTN)
U1111-1196-0464
Trial acronym
DETRex
Linked study record

Health condition
Health condition(s) or problem(s) studied:
frailty 303028 0
ageing 303184 0
Condition category
Condition code
Public Health 302487 302487 0 0
Health promotion/education
Physical Medicine / Rehabilitation 302626 302626 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants are finishing an exercise program which they have participated in for at least 9 months, and this study will assess their physical decline over three months following the end of the exercise program. Therefore, measurements will be performed twice: once at the end of the nine month exercise program and again 3 months later.
There will not be other measurements
Intervention code [1] 297908 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301907 0
Changes in strength of the upper extremity assessed by the handgrip strength measured by a Jamar dynamometer. Handgrip strength has been related to frailty and also sarcopenia.
Timepoint [1] 301907 0
three months after the cessation of the exercise program, which is the detraining period
Secondary outcome [1] 334395 0
quality of life using the SF-36 Quality of Life Questionnaire
Timepoint [1] 334395 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detarining period
Secondary outcome [2] 334396 0
Change in cardiorrespiratory fitness by the 6 minute walk test measuring the distance covered in meters
Timepoint [2] 334396 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period
Secondary outcome [3] 334397 0
Number of falls by assessing the occurred during the 3 month period by self-report in a study diary
Timepoint [3] 334397 0
The participants will record the number of falls ocurred during the three months of detraining,
Secondary outcome [4] 334398 0
Change in the waist to hip ratio by measuring both the waist and the hip and calculating the ratio
Timepoint [4] 334398 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period

Secondary outcome [5] 334399 0
Changes in dynamic balance performing the “8-foot up and go” test
Timepoint [5] 334399 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period
Secondary outcome [6] 334400 0
changes in the strength of the upper extremity using the “arm curl” test (number of flexions and extensions of the arm within 30 s holding a hand dumbbell)
Timepoint [6] 334400 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period
Secondary outcome [7] 334401 0
changes in blood adiponectin measuring it from venous blood using ELISA technique
Timepoint [7] 334401 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period
Secondary outcome [8] 334402 0
changes in blood interleukin-6 measuring it from the blood using ELISA technique
Timepoint [8] 334402 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period
Secondary outcome [9] 334403 0
changes in blood C-reactive protein measuring it from the blood using ELISA technique
Timepoint [9] 334403 0
Measurements will be undertaken at the end of the exercise programe (baseline) and at 3 months after the cessation of the exercise program, i.e after the 3 months detraining period

Eligibility
Key inclusion criteria
The inclusion criteria will be to be enrolled in a supervised group exercise program for people aged over 65 during the previous 9 months, at least.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-To have serious illnesses that prevents them to undertake physical exercise
-Participate in supervised exercise during the three months of detraining period

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power and sample size
Sample size has been calculated to detect minimal significant effects on the variable of hand-grip strength, accepting a two-sided significance level of 0.05, a clinically relevant improvement of 2 kg in hand-grip strength and a standard deviation of 3 kg, and a power of 90%, 47 individuals are required. Presuming a drop-out of 5%, the resultant sample size is determinate in 50 individuals.
The IBM SPSS Statistics 22 statistical software package (SPSS, Inc., Chicago, IL) will be used to analyse the data. The normal distribution of the data will be evaluated using the Kolmogorov-Smirnov test. Continuous variables will be expressed as mean (SD) when normally distributed and as median with interquartile range (IQR) when not. Categorical variables will be expressed as frequency counts and percentages. To identify significant differences (with respect to baseline) in all variables after the 3 months of detraining, a paired Student’s-T test or a Wilcoxon test for dependent samples will be used.
Statistical significance will be set at p<0.05


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8852 0
Spain
State/province [1] 8852 0
Bizkaia

Funding & Sponsors
Funding source category [1] 296298 0
Government body
Name [1] 296298 0
Basque Goverment
Address [1] 296298 0
C/ Donostia-San Sebastian, 1
1010 Vitoria-Gasteiz
Country [1] 296298 0
Spain
Primary sponsor type
Individual
Name
Susana Gil
Address
University of the Basque Country
Department of Physiology
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa,
Country
Spain
Secondary sponsor category [1] 295335 0
None
Name [1] 295335 0
Address [1] 295335 0
Country [1] 295335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297528 0
Ethics Committee of the University of the Basque Country (UPV/EHU)
Ethics committee address [1] 297528 0
Edificio de Rectorado
Barrio sarriena
Universidad del Pais Vasco/Euskal Herriko Unibertsitatea
Leioa 48940
Bizakaia, Spain
Ethics committee country [1] 297528 0
Spain
Date submitted for ethics approval [1] 297528 0
16/11/2016
Approval date [1] 297528 0
17/12/2016
Ethics approval number [1] 297528 0
M10_2015_204_GIL OROZKO

Summary
Brief summary
The benefits effect of regular exercise has been well characterized. However, less attention has been given to the changes which occur following cessation of activity (detraining) particularly in the elderly.
On many occasions, older adults who habitually attend exercise classes take extended holidays or have breaks and thus they interrupt their exercise. In these situations, it is not uncommon that they complain about stiffness of the joints, increased body pain and a decline in their well-being. Therefore, we hypothesize that old people that habitually exercise will suffer a decline in their physical condition and also their quality of life following the cessation of exercise. The main outcome will be the changes in the strength of the upper extremity measured with the hand-grip strength. Thus, the aim of the present study is to evaluate the effect of 3 months of detraining on different parameters of elderly people who have regularly exercised. In particular, we aim to characterize changes in the physical condition (strength, balance, cardiorespiratory fitness), health related quality of life, number of falls and biochemical parameters.
In order to do that we will recruit a minimum of 50 participants from a supervised physical exercise program offered to people aged over 65 years in a public sports center in Getxo (Bizkaia, Basque Country). The inclusion criteria will be to be enrolled in a supervised group exercise program for people aged over 65 during the previous 9 months, at least.
Measurements will be performed twice: once at the end of the nine month exercise program and again 3 months later, which is the detraining period. During detraining, participants will be asked to maintain their normal activities of daily living, and to abstain from participating in supervised exercise programs.
The following measurements will be undertaken:
-Age and gender
-Number of falls which had occurred during the detraining period.
-Anthropometric data: weight, height, circumference of the waist and hip, in order to calculate the body mass index and the waist-hip ratio calculated.
-Health related quality of life using the SF-36 Quality of Life Questionnaire
-6 minute walk test. The distance covered in 6 minutes will be measured (m)
-Dynamic balance performing the “8-foot up and go” test
-Strength of the upper extremity (hand-grip strength) using a hand dynamometry
-Strength of the upper extremity using the “arm curl” test (number of flexions and extensions of the arm within 30 s holding a hand dumbbell)
-Strength of the lower extremity using the “30 s chair stand ”
-Blood adiponectin, interleukin-6 and C-reactive protein measuring it from the blood using ELISA technique

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74338 0
Dr Susana Gil
Address 74338 0
Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n
48940 Leioa
Bizkaia
Country 74338 0
Spain
Phone 74338 0
+34 946012958
Fax 74338 0
Email 74338 0
susana.gil@ehu.eus
Contact person for public queries
Name 74339 0
Dr Susana Gil
Address 74339 0
Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n
48940 Leioa
Bizkaia
Country 74339 0
Spain
Phone 74339 0
+34 946012958
Fax 74339 0
Email 74339 0
susana.gil@ehu.eus
Contact person for scientific queries
Name 74340 0
Dr Susana Gil
Address 74340 0
Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n
48940 Leioa
Bizkaia
Country 74340 0
Spain
Phone 74340 0
+34 946012958
Fax 74340 0
Email 74340 0
susana.gil@ehu.eus

No data has been provided for results reporting
Summary results
Not applicable