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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]

none

Universal Trial Number (UTN)

U1111-1196-0464

Trial acronym

DETRex

Linked study record

Health condition

Health condition(s) or problem(s) studied:

frailty

ageing

Condition category

Condition code

Public Health

Health promotion/education

Physical Medicine / Rehabilitation

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

three months after the cessation of the exercise program, which is the detraining period

Secondary outcome [1]

quality of life using the SF-36 Quality of Life Questionnaire

Timepoint [1]

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]

Change in cardiorrespiratory fitness by the 6 minute walk test measuring the distance covered in meters

Timepoint [2]

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]

Number of falls by assessing the occurred during the 3 month period by self-report in a study diary

Timepoint [3]

The participants will record the number of falls ocurred during the three months of detraining,

Secondary outcome [4]

Change in the waist to hip ratio by measuring both the waist and the hip and calculating the ratio

Timepoint [4]

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]

Changes in dynamic balance performing the “8-foot up and go” test

Timepoint [5]

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]

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]

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]

changes in blood adiponectin measuring it from venous blood using ELISA technique

Timepoint [7]

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]

changes in blood interleukin-6 measuring it from the blood using ELISA technique

Timepoint [8]

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]

changes in blood C-reactive protein measuring it from the blood using ELISA technique

Timepoint [9]

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

Sex

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

31/05/2017

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]

Spain

State/province [1]

Bizkaia

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Basque Goverment

Address [1]

C/ Donostia-San Sebastian, 1
1010 Vitoria-Gasteiz

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the University of the Basque Country (UPV/EHU)

Ethics committee address [1]

Edificio de Rectorado
Barrio sarriena
Universidad del Pais Vasco/Euskal Herriko Unibertsitatea
Leioa 48940
Bizakaia, Spain

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

16/11/2016

Approval date [1]

17/12/2016

Ethics approval number [1]

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

Dr Susana Gil

Address

Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n
48940 Leioa
Bizkaia

Country

Spain

Phone

+34 946012958

Fax

susana.gil@ehu.eus

Contact person for public queries

Name

Susana Gil

Address

Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n
48940 Leioa
Bizkaia

Country

Spain

Phone

+34 946012958

Fax

susana.gil@ehu.eus

Contact person for scientific queries

Name

Susana Gil

Address

Department of Physiology
Faculty of Medicine and Nursing
University of the Basque Country (UPV/EHU)
Barrio Sarriena s/n
48940 Leioa
Bizkaia

Country

Spain

Phone

+34 946012958

Fax

susana.gil@ehu.eus

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Plain language summary	No	BACKGROUND: Little is known about the effects of ... [More Details]
Study results article	Yes	Esain, I., Rodriguez-Larrad, A., Bidaurrazaga-Leto... [More Details]
Other files	No	Esain, I., Rodriguez-Larrad, A., Bidaurrazaga-Leto... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Health-related quality of life, handgrip strength and falls during detraining in elderly habitual exercisers.	2017	https://dx.doi.org/10.1186/s12955-017-0800-z
Embase	Exercise cessation in active older adults: Effects on inflammatory markers and adiponectin.	2020	https://dx.doi.org/10.1111/ggi.13907

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically