UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000063376
Receipt number	R000072549
Scientific Title	Safety, acceptability and tolerability of a 12-week high-velocity resistance training programme in community-dwelling older adults: a single-arm pilot study
Date of disclosure of the study information	2026/10/22
Last modified on	2026/10/22 19:31:40

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Basic information

Public title

Safety, acceptability and tolerability of a 12-week high-velocity resistance training programme in community-dwelling older adults: a single-arm pilot study

Acronym

A study to examine whether older adults can safely continue fast-movement strength training

Scientific Title

Safety, acceptability and tolerability of a 12-week high-velocity resistance training programme in community-dwelling older adults: a single-arm pilot study

Scientific Title:Acronym

HVRT-Older Pilot

Region

Japan Europe

Condition

Community-dwelling older adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To examine the safety, acceptability and tolerability of a supervised 12-week high-velocity resistance training (HVRT) programme in community-dwelling older adults, and to describe exploratory changes in inhibitory control, physical function and body composition to inform the design of a future controlled trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Attendance rate (percentage of the 24 scheduled supervised sessions attended during the 12-week intervention), calculated at the end of the intervention (12 weeks after the start of the intervention).

Key secondary outcomes

1) Dropout rate (12 weeks after the start of the intervention)
2) Number of adverse events (e.g., falls, musculoskeletal pain) and proportion of participants with adverse events (from the start of the intervention to 12 weeks)
3) Proportion of sessions in which the prescribed exercises were completed as planned (from the start of the intervention to 12 weeks)
4) Rating of perceived exertion (Borg RPE 6-20) in each session (every session during the intervention)
5) Computerised Stroop task (before the intervention and 12 weeks after the start of the intervention)
6) Handgrip strength (before the intervention and 12 weeks after the start of the intervention)
7) 30-second chair stand test (before the intervention and 12 weeks after the start of the intervention)
8) Mini-BESTest (before the intervention and 12 weeks after the start of the intervention)
9) Body composition (lean mass and fat mass) by DXA (before the intervention and 12 weeks after the start of the intervention)

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

High-velocity resistance training (HVRT) is performed under the supervision of a qualified physiotherapist. The intervention lasts 12 weeks, with 2 sessions per week (24 sessions in total). Each session lasts 45 to 60 minutes (approximately 50 minutes) and consists of a health check, a standardised warm-up (approximately 7 minutes), the main exercises (25 to 35 minutes) and a cool-down. The main exercises are five functional exercises performed wearing a weighted vest: chair stand, forward step-up, lateral step-up, hip hinge and calf raise. The concentric phase is performed as fast as safely possible and the eccentric phase over approximately 5 seconds. Sets and repetitions are 2 sets of 15 repetitions in weeks 1-4, 2 sets of 12 repetitions in weeks 5-8 and 3 sets of 8 repetitions in weeks 9-12. The target rating of perceived exertion (Borg RPE, 6-20) is progressively increased from 13 in week 1 to 17 from week 9. In week 1, participants learn the exercises wearing the vest without additional load. From week 2, the load is increased by approximately 1 to 2% of body weight when the prescribed volume is completed with correct form, RPE is within the target range and there are no safety concerns. The maximum external load is 15% of body weight.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

60 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Community-dwelling adults aged 65-70 years; 2) able to walk independently without assistive devices; 3) able to understand study information and task instructions in Estonian; 4) provided written informed consent

Key exclusion criteria

1) Colour vision deficiency; 2) medical conditions contraindicating exercise, such as unstable cardiovascular disease or uncontrolled hypertension; 3) musculoskeletal or neurological conditions that limit exercise participation; 4) any other condition judged inappropriate by the principal investigator

Target sample size

Research contact person

Name of lead principal investigator

1st name Ivi

Middle name

Last name Vaher

Organization

Tartu Applied Health Sciences University

Division name

Physiotherapy and Environmental Health Department

Zip code

50411

Address

Nooruse tn 5, Tartu

TEL

+372-737-0200

Email

akgrwakgrw@gmail.com

Public contact

Name of contact person

1st name Hiroyasu

Middle name

Last name Murata

Organization

Tartu Applied Health Sciences University

Division name

Physiotherapy and Environmental Health Department

Zip code

50411

Address

Nooruse tn 5, Tartu

TEL

+372-737-0200

Homepage URL

Email

akgrwakgrw@gmail.com

Sponsor or person

Institute

Tartu Applied Health Sciences University

Institute

Department

Personal name

Funding Source

Organization

Nothing

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Research Ethics Committee of the University of Tartu

Address

Ulikooli 18a, 51005 Tartu

Tel

+372-737-6215

Email

eetikakomitee@ut.ee

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2026 Year 10 Month 22 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Preinitiation

Date of protocol fixation

2026 Year 10 Month 22 Day

Date of IRB

Anticipated trial start date

2026 Year 10 Month 24 Day

Last follow-up date

2027 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2026 Year 10 Month 22 Day

Last modified on

2026 Year 10 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072549