NCT07815470

Brief Summary

According to the Global Burden of Disease Study (2017) 64 million people worldwide are living with Heart Failure (HF). Risk factors of HF include age, history of coronary heart disease, atrial fibrillation, hypertension, diabetes mellitus, smoking and low physical activity. There is clear evidence that regular physical activity can increase life expectancy and improve cognitive function, and delay functional disabilities associated with aging. Physical Activity and exercise training is considered as one of the components cardiovascular disease prevention and rehabilitation program. There is a growing scientific support that cardiac rehabilitation (CR) slows, stabilizes or regresses cardiovascular disease (CVD). In addition, it has been shown that CR programs significantly reduce re-hospitalisation and death from CVDs by up to 25%. Despite of strong evidence of the positive effects of exercise training in Chronic HF patients, the adherence to the exercise component of CR is still not at the level recommended by the international physical activity guidelines. Patients participating in physical activity programs are faced with several obstacles, such as orthopaedic limitations to exercise, or being severely overweight. Another most common barriers for participating in CR are family and employment obligation, psychological well-being and age ("CR is only for adults"). Participation of older adults in physical exercises programs is highly influenced by their personal interest in activity type, engagement and perceived advantages. The author is also mentioned that engaging in different types of activities or adding new elements to the traditional exercises may increase and maintain individuals' interest and engagement in physical activity. This will improve their commitment t the regular exercise and leading to improved health outcomes. World Health Organisation defines dance as a type of physical activity and recommends its implementation to develop physical skills, especially in the least active population groups. Scientists highlight the advantages of dancing over traditional strength and balance exercises that are often performed individually, whereas dance is predominantly a group activity. According to the Ministry of Culture of the Republic Azerbaijan, Azerbaijani traditional dances represent the ancient culture of the country and are popular activity among both young and older people. Azerbaijani dancing has a major social role in bringing people together during celebration of National Holidays and family events. However, use of traditional dancing in general, and Azerbaijani dances particularly, as an intervention in CR programs has not been well established. Screening of reports published since 2015, revealed only randomized control studies which identified the dance intervention as national/cultural dancing style. All those studies demonstrated positive impact of traditional dancing on the functional capacity and psychological condition of people with chronic diseases. More research on the use of the cultural dancing as an alternative to traditional exercise programs as a part of CR could provide clearer evidence about the role and effectiveness of traditional dance in CR. The aim of this research is to investigate the impact of Azerbaijani Cultural Dances on cardiorespiratory fitness and quality of life of patients with chronic HF.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Aug 2026Mar 2027

Study Start

First participant enrolled

August 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

August 11, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

heart failuredancingcardiorespiratory fitnessquality of lifemuscle strengthfall risk

Outcome Measures

Primary Outcomes (2)

  • Cardiorespiratory fitness

    Maximal Oxygen Capacity (VO2 max) is consiedered a gold standard in measuring cardiorespiratory fitness. Cardiopulmonary exercise testing will be conducted to all participants to measure cardiorespiratory fitness.

    Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.

  • Quality of Life assessment

    Quality of life (QoL) is one of the factors that is highly impacted in the older adult population and defined as individuals' perception of their position in life in relation to their goals, expectations, standards, and concerns. Research shows that chronic heart failure (CHF) patients experience depression and sleeping disorders, resulting in poor QoL. The QoL will be measured with The Minnesota Living with Heart Failure Questionnaire (MLHFQ). Minimum value for this scale is 0 and maximum value is 105. The lower the score the better the outcome.

    Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.

Secondary Outcomes (2)

  • Muscle Strength

    Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.

  • Fall Risk Assessment

    Day 1 and after 12 weeks of the dancing or exercising intervention. Day 1 after 12 weeks for the control group participants.

Study Arms (3)

Dancing arm. The intervention will last for 12 weeks, with a twice weekly session lasting 60 min.

EXPERIMENTAL

Dance sessions will be delivered by the professional dance instructor who trained to work with older adults. Exercise session - by physiotherapist who is trained and has a bachelor's degree in Sport and Exercise Science. Considering that sessions are going to be conducted with one MD and one Nurse on site, 5-7 participants per each session are permitted for the easy observation and help in case of necessity. Only one dance/exercise instructor will attend the session. Certified MD and nurse will observe the whole session. They both BLS and AED application trained. There is an EAD on site. Lab staff is instructed about contact details of Ambulance and Emergency services. The nearest Ambulance station is in 3 minutes driving distance. Each dancing sessions will consist of three phases: 15 min warm-up, 30 min dance, 15 minutes cooldown period. According to the exercise recommendations in individuals with chronic heart failure, session will consist of aerobic /endurance exercises.

Other: Dancing Intervention

Exercising Group

ACTIVE COMPARATOR

Exercise sessions are going to be designed based on the 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. According to the exercise recommendations in individuals with chronic heart failure, session will consist of aerobic /endurance exercises with low intensity about 40% of VO2 peak. This will continue for about 2 weeks. After 2 weeks the intensity will be gradually increased to 50-65% if tolerated with aiming to reach 70-75% by the end of the 12th week. In addition to the aerobic/endurance training, resistance training exercises will also be added to the structure of the sessions (the intensity level will be kept the same as with aerobic). Warm-up is going to start with very low intensity aerobic/endurance training. Cool-down is stretching exercises and respiratory exercises (10-15 minutes). Before and after each session blood pressure, resting HR and oxygen saturation will be measured.

Other: Exercising

Control Group

NO INTERVENTION

Control group participants will be asked to maintain their normal lifestyle during the 12-week period, including physical activity and social interaction patterns. Participants in the control group will undergo the same pre- and post intervention procedures at T-0 and T- 12.

Interventions

Dance sessions will be delivered by the professional dance instructor who trained to work with older adults. Exercise session - by physiotherapist who is trained and has a bachelor's degree in Sport and Exercise Science. Considering that sessions are going to be conducted with one MD and one Nurse on site, 5-7 participants per each session are permitted for the easy observation and help in case of necessity. Only one dance/exercise instructor will attend the session. Certified MD and nurse will observe the whole session. They both BLS and AED application trained. There is an EAD on site. Each dancing and exercising sessions will consist of three phases: 15 min warm-up, 30 min dance/exercise session, 15 minutes cooldown period. Exercise sessions are going to be designed based on the 2020 ESC Guidelines on sports cardiology and exercise in pat

Dancing arm. The intervention will last for 12 weeks, with a twice weekly session lasting 60 min.

Exercise sessions are going to be designed based on the 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. According to the exercise recommendations in individuals with chronic heart failure, session will consist of aerobic/endurance exercises with low intensity about 40% of VO2 peak. This will continue for about 2 weeks. After 2 weeks the intensity will be gradually increased to 50-65% if tolerated with aiming to reach 70-75% by the end of the 12th week. In addition to the aerobic/endurance training, resistance training exercises will also be added to the structure of the sessions (the intensity level will be kept the same as with aerobic). Warm-up is going to start with very low intensity aerobic/endurance training. Cool-down is stretching exercises and respiratory exercises (10-15 minutes). Before and after each session blood pressure, resting HR and oxygen saturation will be measured.

Exercising Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Echocardiography detected ejection fraction - 40-49% to justify the heart failure
  • Age between 65-85.

You may not qualify if:

  • Age below 65
  • Ejection fraction less than 40% and higher than 49%
  • Structural changes of the myocardium (aneurysms, scars, valvular diseases).
  • Signs of pleural or pericardial effusions
  • Clinically manifested comorbidities (unstable angina)
  • Uncontrolled Cardiac Arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azerbaijan Sports Academy

Baku, AZ1102, Azerbaijan

Location

Related Publications (1)

  • Zhou F, Zhang H, Wang HY, Liu LF, Zhang XG. Barriers and facilitators to older adult participation in intergenerational physical activity program: a systematic review. Aging Clin Exp Res. 2024 Feb 12;36(1):39. doi: 10.1007/s40520-023-02652-z.

    PMID: 38345651BACKGROUND

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will be blinded to participant arm and intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study is going to be designed as a randomized-controlled trial. Participants will be randomised using studyrandomizer.com program which is recommended to use for small studies with up to few hundred participants. 3 arm design will be undertaken with experimental 1 (dancing, DG), experimental 2 (exercising, EG) and control (CG) groups. The intervention will last for 12 weeks, with a twice weekly session lasting 60 min.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

September 11, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Participants personal data includes full name, date of birth, age and gender, contact details and health information. This personal information will be coded and anonymised after the intervention phase of the study. The collected anonymised data will be deleted 7 years after the publication of the results in academic sources. The data will be available to be used for additional and subsequent research purposes within the 7 years period.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The information will be available as soon as the data collection completed until 7 years after.
Access Criteria
The Principal Investigator will have access to the collected research data. UCL Statistician will have access to the anonymised research data. PhD supervisors will be given access to the anonymised data if they request data to answer specific questions.
More information

Locations